510(k) Report

FDA applicant

Tepha, Inc.

Lexington, MA18 decisions2007–20241 recall

FDA records 18 decisions for Tepha, Inc. (Lexington, MA) from 2007 to 2024: 17 510(k) clearances and 1 De Novo grant. Most are in product codes OOD (Surgical Film) and NWJ (Suture, Recombinant Technology). Its devices cite 28 predicates, 14 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Tepha, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 32008: 22009: 12010: 12011: 12012: 22013: 22014: 12016: 12017: 12021: 22024: 1
2007high 3 (2007) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tepha, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tepha, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OODSurgical Film11decisions
  • NWJSuture, Recombinant Technology5decisions
  • OWTMesh, Surgical, Absorbable, Abdominal Hernia1decision
  • FTLMesh, Surgical, Polymeric1decision

Whose devices does it build on?

Its devices cite 28 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070894Tephaflex Surgical MeshTepha, Inc. · 20077cite it
  • K082178Tephaflex Absorbable SutureTepha, Inc. · 20084cite it
  • K113723Tephaflex MeshTepha, Inc. · 20124cite it
  • K111946Tephaflex MeshTepha, Inc. · 20114cite it
  • DEN060003Tephaflex Absorbable SutureTepha, Inc. · 20074cite it
  • K140533Galaflex MeshTepha, Inc. · 20143cite it

What has FDA decided for it lately?

  • K233999GalaFLEX LITE ScaffoldTepha, Inc. · 2024
  • K202425SurgiLattice scaffoldTepha, Inc. · 2021
  • K211307GalaSTITCH Absorbable Monofilament SutureTepha, Inc. · 2021
  • K162922GalaFORM 3DTepha, Inc. · 2017
  • K161092GalaSHAPE 3DTepha, Inc. · 20161 recall
  • K140533Galaflex MeshTepha, Inc. · 2014
  • K132348Tephaflex Braided SutureTepha, Inc. · 2013
  • K130326Tephaflex Meltblown ConstructTepha, Inc. · 2013

All 18 as Tepha, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K161092GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use…Nov 21, 2016Class II