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510(k) K953880

BIOPSY NEEDLE by Biopsys Medical, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
August 18, 1995
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 Biopsys Medical, Inc.

  • K970817 — MICROMARK CLIP (September 11, 1997)
  • K970565 — MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) (March 28, 1997)
  • K963015 — SURGICAL STAPLE MARKER DEVICE (MODIFY) (October 7, 1996)
  • K960019 — RETRACTOR ARM CLAMP (February 9, 1996)
  • K953962 — FORCEPS (September 8, 1995)
  • K951326 — BIOPSY DEVICE ACCESSORY (May 15, 1995)
  • K951229 — MODIFIED BIOPSY NEEDLE (April 6, 1995)
  • K950006 — SURGICAL STAPLE MARKER (March 15, 1995)
  • K943863 — NEEDLE GUIDE (December 29, 1994)
  • K945573 — BIOPSY DEVICE ACCESSORY (December 9, 1994)

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