# Smith & Nephew Inc., Endoscopy Division

- Location (FDA's records): Andover, MA
- FDA decisions: 8 (2007–2013): 8 510(k) clearances
- Product codes: MBI (3), JDR (2), KCT (1), MAI (1), HWC (1)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 46 (2 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew, Inc.: 5 (https://510kreport.com/company/smith-nephew)
- Smith & Nephew Inc., Endoscopy Div.: 1 (https://510kreport.com/company/smith-nephew-endoscopy-div)
- Conmed Linvatec: 1 (https://510kreport.com/company/conmed-linvatec)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Acufex Microsurgical, Inc.: 1 (https://510kreport.com/company/acufex-microsurgical)

## Firms that cite its devices most
- Smith & Nephew, Inc.: 14 (https://510kreport.com/company/smith-nephew)
- Smith & Nephew Endoscopy, Inc.: 5 (https://510kreport.com/company/smith-nephew-endoscopy)
- Dunamis, LLC: 3 (https://510kreport.com/company/dunamis)
- Pivot Medical: 2 (https://510kreport.com/company/pivot-medical)
- Tag Medical Corp.: 2 (https://510kreport.com/company/tag-medical)
- Tornier, Inc.: 2 (https://510kreport.com/company/tornier)
- Parcus Medical, LLC: 2 (https://510kreport.com/company/parcus-medical)
- Smith and Nephew, Inc.: 2 (https://510kreport.com/company/smith-and-nephew)

## Its most-cited devices
- K071586: Bioraptor 2.3 PK Suture Anchor (2007), cited by 23
- K082215: Osteoraptor Suture Anchor (2008), cited by 8
- K081098: Endobutton Continuous Loop (CL) (2008), cited by 6
- K072785: Twinfix FT PK (2007), cited by 6
- K102982: Endobutton Direct (2011), cited by 1
- K070908: Smith & Nephew Kinsa RC Suture Anchor (2007), cited by 1

## Recent decisions
- K121904: Gynecology Sterilization Tray (Mar 11, 2013)
- K102982: Endobutton Direct (Jan 5, 2011)
- K082215: Osteoraptor Suture Anchor (Nov 3, 2008)
- K081098: Endobutton Continuous Loop (CL) (Jul 16, 2008)
- K072785: Twinfix FT PK (Dec 10, 2007)
- K071586: Bioraptor 2.3 PK Suture Anchor (Aug 17, 2007)
- K070908: Smith & Nephew Kinsa RC Suture Anchor (May 16, 2007)
- K070167: Endobutton Direct (Apr 12, 2007)

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