# Ovesco Endoscopy AG

- Location (FDA's records): Tuebingen, DE
- FDA decisions: 16 (2010–2026): 15 510(k) clearances and 1 De Novo grant
- Product codes: PKL (10), GEI (1), OCX (1), FDI (1), KGE (1), PLL (1), QAG (1)
- 510(k) review time since 2016: median 231 days, against 181 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- Elite Medical, Inc.: 1 (https://510kreport.com/company/elite-medical)

## Firms that cite its devices most
- Aponos Medical Corp.: 1 (https://510kreport.com/company/aponos-medical)
- STERIS Corporation: 1 (https://510kreport.com/company/steris)
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)

## Its most-cited devices
- K101428: Otsc (Over-the Scope-Clip) System Set (2010), cited by 3
- K170867: FTRD System Set (2017), cited by 2
- K183309: stentfix OTSC System Set (2019), cited by 1
- K200684: gastroduodenal FTRD Set (2020), cited by 1
- K241858: BARS Set (100.60) (2024), cited by 1

## Recent decisions
- K260487: stentFIX System Set (100.50n) (Oct 2, 2026)
- K253481: colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (Sep 14, 2026)
- K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n) (Dec 18, 2025)
- K242586: ArgoCap (200.52) (May 22, 2025)
- K241858: BARS Set (100.60) (Aug 26, 2024)
- K221385: LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (Aug 11, 2022)
- K200684: gastroduodenal FTRD Set (Jun 2, 2020)
- K183309: stentfix OTSC System Set (Oct 22, 2019)

Source page: https://510kreport.com/company/ovesco-endoscopy