UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG
UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG (Delaware): 510(k) cleared for Karl Storz SE & CO. KG. Its amount of 168 is above the median of 138 (61st percentile). Dated 47 days ago, it serves as a historical benchmark. Score 42/100. 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: 168 · 61th percentile of 414 FDAPulse records · 1.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261102 |
| Device | UNIDRIVE Select System |
| Applicant | Karl Storz SE & CO. KG |
| Specialty / panel | Obstetrics/Gynecology |
| Product code | HIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-03 |
| Decision date | 2026-09-18 |
| Review time (days) | 168 |
| Third-party review | No |
| Applicant location | Tuttlingen, DE |
| amount percentile | 61th of 414 (median 138, 1.2x median) |
| Peer records CSV (25 DE records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG
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.
Free first: a 10-record sample of DE records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG + all 25 DE 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: 2026-09-18
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (DE first): colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gas · Endox High Level Disinfectant (K254094) · Actolind® (06.3637. Actolind® Gel Plus) (K254168) · UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operat · KARL STORZ SUPRALOOP (K254303) · 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: UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG's amount: 61st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 168-day review, longer than typical.
What is the FDAPulse record for UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG in Delaware?
UNIDRIVE Select System (K261102) by Karl Storz SE & CO. KG was cleared on 2026-09-18 after 168 days of review.
How does UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG compare to other Delaware FDAPulse records?
Its amount of 168 sits in the upper half (61th percentile) of 414 records; the median is 138. It is 47 days old; check the official source for later updates before acting.
UNIDRIVE Select System (K261102) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| UNIDRIVE Select System (K261102) | DE | 2026-09-18 |
| UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252) | DE | 2026-09-25 |
| KARL STORZ SUPRALOOP (K254303) | DE | 2026-09-24 |
Related records
- UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG
- KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG
- Everslide (K260117): 510(k) cleared for Special Situations, LLC
- Wearable Breast Pump (Model S36) (K254203): 510(k) cleared for Shenzhen TPH Technology Co., Ltd.
- The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc.
- MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.
- Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.
- FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condom
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Obstetrics & Gynecology devices
More Delaware public-record feeds
Delaware Public Education Organization Directory Pulse in Delaware Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Delaware FEMA Hazard Mitigation Project Tracker in Delaware Federal Alcohol Permit Holder Directory in Delaware New NSF Research Awards by Institution in Delaware School & Library E-Rate Contracts Up for Rebid in Delaware New Grants by Vendor Procurement Need in Delaware Carrier Out-of-Service Alerts in Delaware
How to monitor UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG and peer obstetrics & gynecology records
Get new FDAPulse records like UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG 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.