stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG
stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG (Delaware): 510(k) cleared for Ovesco Endoscopy AG. Its amount of 231 is above the median of 138 (73rd percentile). Dated 34 days ago, it serves as a historical benchmark. Score 48/100. 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: 231 · 73th percentile of 414 FDAPulse records · 1.7x 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 | K260487 |
| Device | stentFIX System Set (100.50n) |
| Applicant | Ovesco Endoscopy AG |
| Specialty / panel | Gastroenterology, Urology |
| Product code | PKL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-13 |
| Decision date | 2026-10-02 |
| Review time (days) | 231 |
| Third-party review | No |
| Applicant location | Tuebingen, DE |
| amount percentile | 73th of 414 (median 138, 1.7x median) |
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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: 2026-10-02
- Data refreshed: 2026-11-04
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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: stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG's amount: 73rd 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)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 231-day review, longer than typical.
- Posted 34 days ago.
What is the FDAPulse record for stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG in Delaware?
stentFIX System Set (100.50n) (K260487) by Ovesco Endoscopy AG was cleared on 2026-10-02 after 231 days of review.
How does stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG compare to other Delaware FDAPulse records?
Its amount of 231 sits in the upper half (73th percentile) of 414 records; the median is 138. It is 34 days old, still within a typical 45-day follow-up window.
stentFIX System Set (100.50n) (K260487) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| stentFIX System Set (100.50n) (K260487) | DE | 2026-10-02 |
| 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 |
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