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510(k) K942626

CONTINUOUS FLOW BIOPSY PROBE by Gm Engineering, Inc. — Product Code FDC

K942626 is an FDA 510(k) premarket notification submitted by Gm Engineering, Inc. for the device "CONTINUOUS FLOW BIOPSY PROBE". The FDA issued a decision of Substantially Equivalent on May 30, 1995. The device falls under product code FDC (Resectoscope, Working Element), 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 30, 1995
Date Received
June 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope, Working Element
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Gm Engineering, Inc.

  • K953348 — ARTICULATING RETRACTOR TISSUE RETRACTORS (September 12, 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)
  • 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 FDC

  • K021166 — ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR (May 9, 2002)
  • K992141 — OLYMPUS WORKING ELEMENT FOR PROBES (September 29, 1999)
  • K991426 — MAHE INSTRUMENTS (August 5, 1999)
  • K933962 — GM CONTINUOUS FLOW BIOPSY PROBE (February 25, 1994)
  • K895643 — MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM (October 17, 1989)
  • K894363 — UROPUMP* FLUID MANAGEMENT SYSTEM (August 11, 1989)
  • K842997 — LASER RECTOSCOPE SET 784 (August 27, 1984)
  • K760184 — ELEMENT, WORKING (December 2, 1976)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)
  • K760174 — ADAPTER, RESECTOSCOPE (August 30, 1976)

FDA data resources