510(k) Report

FDA applicant

Medspec Corp.

Mchenry, IL15 decisions1980–19810 recalls

FDA records 15 decisions for Medspec Corp. (Mchenry, IL) from 1980 to 1981: 15 510(k) clearances. Most are in product codes GDY (Gauze/Sponge, Internal, X-Ray Detectable) and KKX (Drape, Surgical, Antimicrobial). 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 Medspec Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medspec Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medspec Corp.’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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