510(k) Report

FDA applicant

Gorbec Pharmaceutical Services, Inc.

Durham, NC3 decisions2008–20100 recalls

FDA records 3 decisions for Gorbec Pharmaceutical Services, Inc. (Durham, NC) from 2008 to 2010: 3 510(k) clearances. Most are in product codes NAE (Dressing, Wound, Hydrogel Without Drug And/Or…) and FRO (Dressing, Wound, Drug). Its devices cite 3 predicates, 1 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 Gorbec Pharmaceutical Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 22010: 1
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Gorbec Pharmaceutical Services, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gorbec Pharmaceutical Services, 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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