Home / 510(k) Clearances / K950311

510(k) K950311

GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE by Global Medical Products, Ltd. — Product Code GDF

K950311 is an FDA 510(k) premarket notification submitted by Global Medical Products, Ltd. for the device "GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE". The FDA issued a decision of Substantially Equivalent on May 26, 1995. The device falls under product code GDF (Guide, Needle, Surgical), a Class I device regulated under 21 CFR 878.4800. Global Medical Products, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1995
Date Received
January 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Needle, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • K951421 — GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREEN (November 16, 1995)

Other clearances for product code GDF

  • K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 (July 23, 2003)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K945124 — BREAST LESION LOCALIZATION NEEDLE (November 22, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)
  • K924270 — BREAST LESION LOCALIZATION NEEDLE (September 23, 1992)

FDA data resources