510(k) Report

FDA applicant

Frigitronics, Inc.

Mountain View, CA3 decisions1991–19910 recalls

FDA records 3 decisions for Frigitronics, Inc. (Mountain View, CA) in 1991: 3 510(k) clearances. Most are in product codes HIG (Insufflator, Hysteroscopic) and HIH (Hysteroscope (And Accessories)). 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 Frigitronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Frigitronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Frigitronics, 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 “Frigitronics”

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