FDA applicant

American Surgical Instruments Corp.

Delray Beach, FL6 decisions1990–19930 recalls

FDA records 6 decisions for American Surgical Instruments Corp. (Delray Beach, FL) from 1990 to 1993: 6 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and GCJ (Laparoscope, General & Plastic Surgery). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided American Surgical Instruments Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Surgical Instruments Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Surgical Instruments Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?