colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG (Delaware): 510(k) cleared for Ovesco Endoscopy AG. Its amount of 335 is top-decile (97th percentile of 414 records). Dated 52 days ago, it serves as a historical benchmark. Score 55/100. 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: 335 · 97th percentile of 414 FDAPulse records · 2.4x 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 | K253481 |
| Device | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) |
| Applicant | Ovesco Endoscopy AG |
| Specialty / panel | Gastroenterology, Urology |
| Product code | PKL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-10-14 |
| Decision date | 2026-09-14 |
| Review time (days) | 335 |
| Third-party review | No |
| Applicant location | Tuebingen, DE |
| amount percentile | 97th of 414 (median 138, 2.4x median) |
| Peer records CSV (25 DE 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: 2026-09-14
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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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: colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG's amount: 97th 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)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 335-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG in Delaware?
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) by Ovesco Endoscopy AG was cleared on 2026-09-14 after 335 days of review.
How does colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG compare to other Delaware FDAPulse records?
This is a top-decile record: its amount of 335 is 2.4x the median of 138 across 414 records. It is 52 days old; check the official source for later updates before acting.
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| 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 | IN | 2026-10-23 |
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