510(k) Report

FDA applicant

Collafirm, LLC

Monmouth Jct, NJ2 decisions2013–20140 recalls

FDA records 2 decisions for Collafirm, LLC (Monmouth Jct, NJ) from 2013 to 2014: 2 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 3 predicates, 0 of them its own earlier devices. No 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 Collafirm, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 12014: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Collafirm, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FTMMesh, Surgical1decision
  • KGNWound Dressing With Animal-Derived Material (S)1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K141721Bovine Pericardium PatchCollafirm, LLC · 2014
  • K120250Fibrillar Collagen Wound DressingCollafirm, LLC · 2013

All 2 as Collafirm, LLC →