# Tepha, Inc.

- Location (FDA's records): Lexington, MA
- FDA decisions: 18 (2007–2024): 17 510(k) clearances and 1 De Novo grant
- Product codes: OOD (11), NWJ (5), OWT (1), FTL (1)
- Predicates its devices cite: 28 (14 its own); citations of its devices by later devices: 31 (14 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ETHICON, Inc.: 4 (https://510kreport.com/company/ethicon)
- Macropore Biosurgery, Inc.: 2 (https://510kreport.com/company/macropore-biosurgery)
- Mast Biosurgery USA, Inc.: 2 (https://510kreport.com/company/mast-biosurgery-usa)
- Tornier, Inc.: 2 (https://510kreport.com/company/tornier)
- Allergan, Inc.: 1 (https://510kreport.com/company/allergan)
- Davis & Geck, Inc.: 1 (https://510kreport.com/company/davis-geck)
- Cook Biotech, Inc.: 1 (https://510kreport.com/company/cook-biotech)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)

## Firms that cite its devices most
- Tornier, Inc.: 6 (https://510kreport.com/company/tornier)
- C.R. Bard, Inc.: 5 (https://510kreport.com/company/cr-bard)
- Aesculap, Inc.: 3 (https://510kreport.com/company/aesculap)
- C. R. Bard: 3 (https://510kreport.com/company/c-r-bard)

## Its most-cited devices
- K070894: Tephaflex Surgical Mesh (2007), cited by 7
- K082178: Tephaflex Absorbable Suture (2008), cited by 4
- K113723: Tephaflex Mesh (2012), cited by 4
- K111946: Tephaflex Mesh (2011), cited by 4
- DEN060003: Tephaflex Absorbable Suture (2007), cited by 4
- K140533: Galaflex Mesh (2014), cited by 3

## Recent decisions
- K233999: GalaFLEX LITE Scaffold (Apr 9, 2024)
- K202425: SurgiLattice scaffold (Aug 19, 2021)
- K211307: GalaSTITCH Absorbable Monofilament Suture (May 27, 2021)
- K162922: GalaFORM 3D (Feb 23, 2017)
- K161092: GalaSHAPE 3D (Aug 23, 2016)
- K140533: Galaflex Mesh (May 21, 2014)
- K132348: Tephaflex Braided Suture (Sep 5, 2013)
- K130326: Tephaflex Meltblown Construct (May 7, 2013)

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