510(k) Report

FDA applicant

Unisurge, Inc.

Cupertino, CA12 decisions1992–19940 recalls

FDA records 12 decisions for Unisurge, Inc. (Cupertino, CA) from 1992 to 1994: 12 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GDO (Applier, Surgical, Clip). 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 Unisurge, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unisurge, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Unisurge”

FDA records each applicant name separately; these may or may not be the same firm.