FDA applicant

Surgicon, Inc.

Stratford, CT2 decisions2002–20030 recalls

FDA records 2 decisions for Surgicon, Inc. (Stratford, CT) from 2002 to 2003: 2 510(k) clearances. Most are in product codes GCI (Laryngoscope, Endoscope) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 1 predicate, 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Surgicon, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surgicon, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Surgicon, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?