Home / 510(k) Clearances / K951421

510(k) K951421

GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES by Global Medical Products, Ltd. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1995
Date Received
March 28, 1995
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 Global Medical Products, Ltd.

  • K970916 — H.V. PULSE LAVAGE (L31 SERIES) (June 20, 1997)
  • K962821 — EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT (November 13, 1996)
  • K961444 — GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) (August 1, 1996)
  • K951448 — GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED S (March 27, 1996)
  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)

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)