# Smith & Nephew Endoscopy, Inc.

- Location (FDA's records): Mansfield, MA
- FDA decisions: 18 (1996–2011): 18 510(k) clearances
- Product codes: MBI (4), HWC (3), HRX (2), OCW (2), GEY (1), GEI (1), MAI (1), KGS (1), HTN (1), GCJ (1), GAT (1)
- Predicates its devices cite: 21 (0 its own); citations of its devices by later devices: 39 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew Inc., Endoscopy Division: 5 (https://510kreport.com/company/smith-nephew-endoscopy-division)
- Arthrex, Inc.: 5 (https://510kreport.com/company/arthrex)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Future Medical Systems, Inc.: 2 (https://510kreport.com/company/future-medical-systems)
- Smith & Nephew Inc., Endoscopy Div.: 1 (https://510kreport.com/company/smith-nephew-endoscopy-div)
- Smith & Nephew Dyonics, Inc.: 1 (https://510kreport.com/company/smith-nephew-dyonics)
- W.O.M. World of Medicine GmbH: 1 (https://510kreport.com/company/wom-world-of-medicine)
- Mitek Products: 1 (https://510kreport.com/company/mitek-products)

## Firms that cite its devices most
- Smith & Nephew, Inc.: 15 (https://510kreport.com/company/smith-nephew)
- Depuy Mitek, A Johnson & Johnson Company: 2 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Dunamis, LLC: 2 (https://510kreport.com/company/dunamis)
- Smith and Nephew, Inc.: 2 (https://510kreport.com/company/smith-and-nephew)
- Fournitures Hospitalieres Industrie: 2 (https://510kreport.com/company/fournitures-hospitalieres-industrie)
- International Life Sciences: 1 (https://510kreport.com/company/international-life-sciences)
- Signature Orthopaedics Pty, Ltd.: 1 (https://510kreport.com/company/signature-orthopaedics)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)

## Its most-cited devices
- K083635: Smith & Nephew Biosure PK Interference Screw (2009), cited by 11
- K093428: Smith & Nephew Knotless Instability Anchor (2009), cited by 8
- K992396: Biorci Screw (2000), cited by 5
- K083226: Smith & Nephew Peek Interference Screw (2009), cited by 4
- K082095: Ultraslide Acromioclavicular and Syndesmotic Repair Device (2008), cited by 3
- K102660: Bioraptor Curved 2.3 PK Suture Anchors (2010), cited by 2

## Recent decisions
- K103309: Osteoraptor Curved 2.3 Suture Anchors (Feb 3, 2011)
- K102660: Bioraptor Curved 2.3 PK Suture Anchors (Dec 13, 2010)
- K093428: Smith & Nephew Knotless Instability Anchor (Dec 17, 2009)
- K083635: Smith & Nephew Biosure PK Interference Screw (Jan 30, 2009)
- K083226: Smith & Nephew Peek Interference Screw (Jan 30, 2009)
- K082095: Ultraslide Acromioclavicular and Syndesmotic Repair Device (Oct 21, 2008)
- K050580: Smith & Nephew Intelijet Fluid Management Systems (Apr 20, 2005)
- K992396: Biorci Screw (Jan 12, 2000)

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