Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical)
Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical). Its amount of 119 is below the median of 138 (44th percentile). Dated 22 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-04, 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: 119 · 44th percentile of 414 FDAPulse records · 0.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 2 related NL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262044 |
| Device | Mediclose Cartridge System |
| Applicant | Health Value Creation B.V. (trading as Corporis Medical) |
| Specialty / panel | Gastroenterology, Urology |
| Product code | OCW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-17 |
| Decision date | 2026-10-14 |
| Review time (days) | 119 |
| Third-party review | No |
| Applicant location | Maastricht, NL |
| amount percentile | 44th of 414 (median 138, 0.9x median) |
| Peer records CSV (3 NL records) | 🔒 Click to unlock → |
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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: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (NL first): QGuideCT (1.0) (K260523) · GANNET® (K262184) · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · TECAR Therapy Device (TC2000, TC2001) (K252288) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical) and 3 NL peers
- NL FDAPulse records like this one: 3
- Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical)'s amount: 44th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every NL peer: $600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 119-day review: this device is a strong predicate for similar products.
- Posted 22 days ago.
What is the FDAPulse record for Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical)?
Mediclose Cartridge System (K262044) by Health Value Creation B.V. (trading as Corporis Medical) was cleared on 2026-10-14 after 119 days of review.
How does Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical) compare to other FDAPulse records?
Its amount of 119 is below the median (44th percentile); smaller records often move faster and face less competition. It is 22 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.
Mediclose Cartridge System (K262044) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Mediclose Cartridge System (K262044) | NL | 2026-10-14 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
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
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Gastroenterology & Urology devices
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