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510(k) K941662

GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT by Gm Engineering, Inc. — Product Code EQH

K941662 is an FDA 510(k) premarket notification submitted by Gm Engineering, Inc. for the device "GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT". The FDA issued a decision of Substantially Equivalent on July 20, 1994. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Gm Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1994
Date Received
April 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by Gm Engineering, Inc.

  • K953348 — ARTICULATING RETRACTOR TISSUE RETRACTORS (September 12, 1995)
  • K942626 — CONTINUOUS FLOW BIOPSY PROBE (May 30, 1995)
  • K932394 — BERNSTEIN(TM) UTERINE MANIPULATOR (January 26, 1995)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K942703 — GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CAN (August 19, 1994)
  • K941660 — GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT (May 24, 1994)
  • K933962 — GM CONTINUOUS FLOW BIOPSY PROBE (February 25, 1994)
  • K930611 — TRUE FLOW(TM) VALVE (December 1, 1993)
  • K934035 — GM MONOPOLAR/FRAZIER SUCTION PROBE (December 1, 1993)
  • K931398 — GM SWIVEL VIDEO (TM) IRRIGATOR (August 30, 1993)

Other clearances for product code EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)
  • K923227 — THROAT-A-SCOPE (December 4, 1992)

FDA data resources