FDA applicant

General Surgical Innovations

Palo Alto, CA14 decisions1993–19990 recalls

FDA records 14 decisions for General Surgical Innovations (Palo Alto, CA) from 1993 to 1999: 14 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and DYB (Introducer, Catheter). Its devices cite 17 predicates, 8 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for General Surgical Innovations since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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General Surgical Innovations

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?