Medical Device Manufacturer · US , La Verne , CA

Gm Engineering, Inc.

11 submissions · 11 cleared · Since 1993
11
Total
11
Cleared
0
Denied

Gm Engineering, Inc. — FDA 510(k) Submissions

Gm Engineering, Inc. has submitted 11 FDA 510(k) premarket notifications since 1993, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laparoscope, General & Plastic Surgery, Resectoscope, Working Element, Source, Carrier, Fiberoptic Light, Powered Laser Surgical Instrument, Irrigator, Sinus . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
ARTICULATING RETRACTOR TISSUE RETRACTORS
K953348 · GCJ Laparoscope, General &... · General & Plastic Surgery
Sep 1995 57d
CONTINUOUS FLOW BIOPSY PROBE
K942626 · FDC Resectoscope, Working... · Gastroenterology & Urology
May 1995 362d
BERNSTEIN(TM) UTERINE MANIPULATOR
K932394 · LKF Cannula,... · Obstetrics & Gynecology
Jan 1995 618d
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT
K941661 · EQH Source, Carrier,... · Ear, Nose, Throat
Aug 1994 140d
GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA
K942703 · GCJ Laparoscope, General &... · General & Plastic Surgery
Aug 1994 72d
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
K941662 · EQH Source, Carrier,... · Ear, Nose, Throat
Jul 1994 106d
GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT
K941660 · KYH Endoscope, Ophthalmic · Ophthalmic
May 1994 49d
GM CONTINUOUS FLOW BIOPSY PROBE
K933962 · FDC Resectoscope, Working... · Gastroenterology & Urology
Feb 1994 196d
TRUE FLOW(TM) VALVE
K930611 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 1993 299d
GM MONOPOLAR/FRAZIER SUCTION PROBE
K934035 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 1993 105d
GM SWIVEL VIDEO (TM) IRRIGATOR
K931398 · KAR Irrigator, Sinus · Ear, Nose, Throat
Aug 1993 164d
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