510(k) Report

FDA applicant

Igi Laboratories, Inc.

Buena, NJ2 decisions2013–20130 recalls

FDA records 2 decisions for Igi Laboratories, Inc. (Buena, NJ) in 2013: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 2 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

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

FDA decisions per year

2in 2013

2013: 2
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

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

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

See the 510(k) Report

Which product codes does it file in?

  • FRODressing, Wound, Drug2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K123724Dermiseb CreamIgi Laboratories, Inc. · 20131cites it

What has FDA decided for it lately?

  • K123678Hyalmix CreamIgi Laboratories, Inc. · 2013
  • K123724Dermiseb CreamIgi Laboratories, Inc. · 2013

All 2 as Igi Laboratories, Inc. →