stentfix OTSC System Set— 510(k) K183309

Clearance details

Applicant

Ovesco Endoscopy AG

Product code

Code PKL

Device class

Class 2

Regulation

21 CFR 876.4400

Advisory panel

Gastroenterology, Urology

Date received

2018-11-29

Decision date

2019-10-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tuebingen, DE

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• K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)2025-12-18

• K242586 — ArgoCap (200.52)2025-05-22
• K241858 — BARS Set (100.60)2024-08-26
• K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)2022-08-11
• K200684 — gastroduodenal FTRD Set2020-06-02
• DEN160014 — remOVE System2017-12-22

Death

9

Injury

489

Malfunction

4,698

Other

1

Total

5,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →