FDA 510(k) clearance · back to tracker

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

Ovesco Endoscopy AG cleared K253481 on 2026-09-14, decision: substantially equivalent

K-number

K253481

Sponsor

Ovesco Endoscopy AG

Device

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-09-14

Product code

PKL

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.4400

Official FDA record

Open K253481on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.