# colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG

**Predicate Speed & CAPA Advisory Opportunity Score:** 55/100

| 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 |

## Why this score
- A long 335-day review suggests additional-information requests: a firm likely to value regulatory help next time.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253481). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.