510(k) Report

FDA applicant

Gm Engineering, Inc.

La Verne, CA11 decisions1993–19950 recalls

FDA records 11 decisions for Gm Engineering, Inc. (La Verne, CA) from 1993 to 1995: 11 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and EQH (Source, Carrier, Fiberoptic Light). 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 Gm Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gm Engineering, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gm Engineering, 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?

  • GCJLaparoscope, General & Plastic Surgery2decisions
  • EQHSource, Carrier, Fiberoptic Light2decisions
  • FDCResectoscope, Working Element2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • KYHEndoscope, Ophthalmic1decision
  • LKFCannula, Manipulator/Injector, Uterine1decision

Also: GEX (1), KAR (1).

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K942703GM Reusable and Disposable Trocar and GM Reusable and Disposable Ultra-Light CannulaGm Engineering, Inc. · 19941cites it

What has FDA decided for it lately?

  • K953348Articulating Retractor Tissue RetractorsGm Engineering, Inc. · 1995
  • K942626Continuous Flow Biopsy ProbeGm Engineering, Inc. · 1995
  • K932394Bernstein (TM) Uterine ManipulatorGm Engineering, Inc. · 1995
  • K941661GM Opti*Cam Camer with Dental Fiber Optic LightGm Engineering, Inc. · 1994
  • K942703GM Reusable and Disposable Trocar and GM Reusable and Disposable Ultra-Light CannulaGm Engineering, Inc. · 1994
  • K941662GM Opti*Cam Camera with Ent Fiber Optic LightGm Engineering, Inc. · 1994
  • K941660GM Opti*Cam Camera with Fiber Optic LightGm Engineering, Inc. · 1994
  • K933962GM Continuous Flow Biopsy ProbeGm Engineering, Inc. · 1994

All 11 as Gm Engineering, Inc. →