510(k) Report

FDA applicant

Surgical Technologies, Inc.

Miami Lakes, FL28 decisions1991–19950 recalls

FDA records 28 decisions for Surgical Technologies, Inc. (Miami Lakes, FL) from 1991 to 1995: 28 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HQE (Instrument, Vitreous Aspiration And Cutting…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Surgical Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surgical Technologies, 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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