510(k) Report

FDA applicant

Micro-Coll

Bangor, PA1 decision1992–19920 recalls

FDA records 1 decision for Micro-Coll (Bangor, PA) in 1992: 1 510(k) clearance. All are in product code SEJ (Wound Dressings Containing Topical Analgesics). No recall is linked to its devices.

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

How often FDA has decided Micro-Coll’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Micro-Coll since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • SEJWound Dressings Containing Topical Analgesics1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K912565Micro-Coll Collagen Wound SprayMicro-Coll · 19921cites it

What has FDA decided for it lately?

  • K912565Micro-Coll Collagen Wound SprayMicro-Coll · 1992

The one decision as Micro-Coll →