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510(k) K942626

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

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

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  • K933962 — GM CONTINUOUS FLOW BIOPSY PROBE (February 25, 1994)
  • K934035 — GM MONOPOLAR/FRAZIER SUCTION PROBE (December 1, 1993)
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  • 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)