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510(k) K861267

UROCUT BIOPSY NEEDLE by Meadox Surgimed, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
April 4, 1986
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

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  • 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)
  • K902461 — MEADOX SURGIMED BIOPSY GUN AND NEEDLE (July 16, 1990)
  • K890926 — SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE (June 20, 1989)

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