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510(k) K944252

BIOPSY DEVICE ACCESSORY by Biopsys Medical, Inc. — Product Code FCK

K944252 is an FDA 510(k) premarket notification submitted by Biopsys Medical, Inc. for the device "BIOPSY DEVICE ACCESSORY". The FDA issued a decision of Substantially Equivalent on December 5, 1994. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. Biopsys Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1994
Date Received
August 30, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy, Suction
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
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)
  • K953880 — BIOPSY NEEDLE (September 8, 1995)
  • 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)

Other clearances for product code FCK

  • K153763 — Howell Biliary Aspiration Needle (April 6, 2017)
  • K103326 — MULTIPLE BIOPSY SYSTEM (April 6, 2011)
  • K062159 — RB12 SUCTION RECTAL BIOPSY SYSTEM (September 5, 2006)
  • K061201 — DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 (May 30, 2006)
  • K051637 — DSNARE, MODEL 00711087 (October 31, 2005)
  • K954693 — MEHTA BRONCHIAL BIOSPY DRILL (October 23, 1995)
  • K932142 — SUCTION GUILLOTINE DEVICE (September 24, 1993)
  • K911448 — MULTIPLE BIOPSY DEVICE-MBX (April 16, 1991)
  • K902910 — CYTOASPIRATOR (January 16, 1991)
  • K902097 — MODEL TR RECTAL SUCTION BIOPSY TUBE (July 27, 1990)

FDA data resources