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510(k) K902461

MEADOX SURGIMED BIOPSY GUN AND NEEDLE by Meadox Surgimed, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1990
Date Received
June 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Meadox Surgimed, Inc.

  • K944143 — MS CLASSIQUE BALLOON CATHETER (March 13, 1995)
  • K945061 — NOPROFILE OLBERT CATHETER SYSTEM (March 9, 1995)
  • K942382 — MS AMPLATZ EXTRA STIFF GUIDE WIRE (August 22, 1994)
  • K930201 — ACECUT SUTOMATIC BIOPSY SYSTEM (June 9, 1993)
  • K911635 — MEADOX(R) SURGIMED(R) BIOPSY GUN II (June 20, 1991)
  • K905181 — NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY (March 6, 1991)
  • K904582 — QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE (February 25, 1991)
  • K904983 — MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY (January 30, 1991)
  • K890926 — SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE (June 20, 1989)
  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)

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