# Suzhou Endophix Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 4 (2023–2024): 4 510(k) clearances
- Product codes: MBI (4)
- 510(k) review time since 2016: median 59 days, against 57 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 19 (0 its own); citations of its devices by later devices: 0 (0 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
- Arthrex, Inc.: 9 (https://510kreport.com/company/arthrex)
- Smith & Nephew, Inc.: 4 (https://510kreport.com/company/smith-nephew)
- Smith & Nephew Inc., Endoscopy Div.: 3 (https://510kreport.com/company/smith-nephew-endoscopy-div)
- Depuy Mitek, A Johnson & Johnson Company: 1 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)
- Smith & Nephew Endoscopy, Inc.: 1 (https://510kreport.com/company/smith-nephew-endoscopy)

## Recent decisions
- K232941: Megaloop Button System (May 3, 2024)
- K232725: Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor (Nov 2, 2023)
- K231002: Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) (Jun 7, 2023)
- K230874: Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath (May 23, 2023)

Source page: https://510kreport.com/company/suzhou-endophix