510(k) Report

FDA applicant

Gs Medical Packaging, Inc.

Minneapolis, MN2 decisions1995–20140 recalls

FDA records 2 decisions for Gs Medical Packaging, Inc. (Minneapolis, MN) from 1995 to 2014: 2 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and KCT (Sterilization Wrap Containers, Trays…). Its devices cite 1 predicate, 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 hospital panel, where it files most

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

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gs Medical Packaging, 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?

  • FRGWrap, Sterilization1decision
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K141412Sterilucent Self-Seal Sterilization PouchGs Medical Packaging, Inc. · 2014
  • K953829Safe-T-SealGs Medical Packaging, Inc. · 1995

All 2 as Gs Medical Packaging, Inc. →