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510(k) K010400

VACUUM ASSISTED CORE BIOPSY DEVICE by Promex, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2001
Date Received
February 12, 2001
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 Promex, Inc.

  • K023450 — BIOPSY SITE TISSUE MARKER DEVICE (December 19, 2002)
  • K022634 — CO-AXIAL INTRODUCER NEEDLE (November 6, 2002)
  • K011270 — AUTOMATED CORE BIOPSY DEVICE (June 22, 2001)
  • K001132 — BONE BIOPSY NEEDLE (May 1, 2000)
  • K994272 — AUTOMATED CORE BIOPSY DEVICE (January 7, 2000)
  • K993435 — MANUAL BONE MARROW BIOPSY DEVICE (December 6, 1999)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K972865 — PROMEX ENT TISSUE REMOVAL SYSTEM (September 29, 1997)
  • K961078 — AUTOMATED VITRECTOMY DEVICE (June 14, 1996)
  • K960023 — KIRSHNER WIRES (K-WIRE) & STEINMANN PINS (March 18, 1996)

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