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510(k) K941660

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

K941660 is an FDA 510(k) premarket notification submitted by Gm Engineering, Inc. for the device "GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT". The FDA issued a decision of Substantially Equivalent on May 24, 1994. The device falls under product code KYH (Endoscope, Ophthalmic), a Class II device regulated under 21 CFR 876.1500. Gm Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1994
Date Received
April 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Ophthalmic
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
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)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 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)

FDA data resources