# Novatech SA

- Location (FDA's records): La Ciotat Cedex, FR
- FDA decisions: 5 (1997–2025): 5 510(k) clearances
- Product codes: GCJ (2), NWA (2), EOQ (1)
- 510(k) review time since 2016: median 184 days, against 99 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 7 (2 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
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Bryan Corp.: 1 (https://510kreport.com/company/bryan)

## Firms that cite its devices most
- Alveolus, Inc.: 3 (https://510kreport.com/company/alveolus)
- New Cos, Inc.: 1 (https://510kreport.com/company/new-cos)
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)

## Its most-cited devices
- K971509: Endoxane (1997), cited by 6
- K151832: Novatech Talcair (2016), cited by 1

## Recent decisions
- K242324: Dutau-Novatech® (Feb 6, 2025)
- K243126: Tracheobronxane™ Dumon® (Oct 29, 2024)
- K170030: Novatech Talcair (Mar 13, 2017)
- K151832: Novatech Talcair (Mar 31, 2016)
- K971509: Endoxane (Aug 21, 1997)

Source page: https://510kreport.com/company/novatech