Home / 510(k) Clearances / K945133

510(k) K945133

MODIFIED BIOPSY NEEDLE by Biopsys Medical, Inc. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1994
Date Received
October 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
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 FCG

  • K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
  • K250994 — ClearTip FNA and FNB Types (August 21, 2025)
  • K241209 — EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (July 29, 2024)
  • K231422 — Precision GI (August 28, 2023)
  • K231267 — ClearTip (June 30, 2023)
  • K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (May 30, 2023)
  • K212423 — EndoDrill® Model X (March 29, 2023)
  • K212819 — Disposable Biopsy Refill Needle (July 6, 2022)
  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
  • K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy (May 20, 2021)