510(k) Report

FDA applicant

Bei Medical Systems Co., Inc.

Hackensack, NJ4 decisions1994–19970 recalls

FDA records 4 decisions for Bei Medical Systems Co., Inc. (Hackensack, NJ) from 1994 to 1997: 4 510(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 Bei Medical Systems Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bei Medical Systems Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HIGInsufflator, Hysteroscopic1decision
  • HIHHysteroscope (And Accessories)1decision
  • FYDApparatus, Exhaust, Surgical1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

What has FDA decided for it lately?

  • K971492Automatic Electronic Hysteroscopic InsufflatorBei Medical Systems Co., Inc. · 1997
  • K950663Bei Medical Systems MG-1000HS Monopolar GeneratorBei Medical Systems Co., Inc. · 1995
  • K934286HysteroscopeBei Medical Systems Co., Inc. · 1994
  • K940266Bei Medical Systems' Smoke EvacuatorBei Medical Systems Co., Inc. · 1994

All 4 as Bei Medical Systems Co., Inc. →