da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc.
da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc. (California): 510(k) cleared for Intuitive Surgical, Inc. Its amount of 89 is below the median of 138 (29th percentile). Dated 21 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 89 · 29th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262455 |
| Device | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System |
| Applicant | Intuitive Surgical, Inc. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | GCJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-17 |
| Decision date | 2026-10-14 |
| Review time (days) | 89 |
| Third-party review | No |
| Applicant location | Sunnyvale, CA, US |
| amount percentile | 29th of 414 (median 138, 0.6x median) |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical + all 76 CA records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-14
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CA first): Triever Duo Catheter (K253419) · Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc.'s amount: 29th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 89-day review: this device is a strong predicate for similar products.
- Posted 21 days ago.
What is the FDAPulse record for da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc. in California?
da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455) by Intuitive Surgical, Inc. was cleared on 2026-10-14 after 89 days of review.
How does da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc. compare to other California FDAPulse records?
Its amount of 89 is below the median (29th percentile); smaller records often move faster and face less competition. It is 21 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455) | CA | 2026-10-14 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Rapid Barostat Bag (RBB) Pump and Catheter System (K262621) | CA | 2026-09-30 |
Related records
- CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc.
- Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.
- colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG
- Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin
- Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) (K260708): 510(k) cleared for Vein 360
- multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC
- OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc.
- stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG
- Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- CADDIE (K260133): 510(k) cleared for Odin Medical Limited
- Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Gastroenterology & Urology devices
More California public-record feeds
New Trucking Company Registrations in California FMCSA Trucking Insurance Cancellations by Carrier, Insurer & Fleet Size in California New Executive & Auditor Changes (SEC 8-K) in California Carrier Out-of-Service Alerts in California Newly CLIA-Certified Laboratories by State & Certificate in California New WARN Act Layoff & Closure Notices with Headcount and Site Address in California New MSHA Citations at Mines & Quarries by State in California DOE grid resilience Award Tracker in California
How to monitor da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc. and peer gastroenterology & urology records
Get new FDAPulse records like da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.