510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K950311Substantially Equivalent

Global Medical Products Brest Lesion Localization Needle with Stiffened Wire

Global Medical Products, Ltd., Woodbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950311 is the FDA 510(k) clearance record for GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE, a class I device, cleared for Global Medical Products, Ltd. on under FDA product code GDF (Guide, Needle, Surgical). FDA records list 6 510(k) clearances for Global Medical Products, Ltd., from to . As of , FDA records show no recalls naming K950311.

Clearance record

Decision date
Received
(130 days to decision)
Product code
GDF Guide, Needle, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Global Medical Products, Ltd. 244 Main St., S., Woodbury CT
510(k) summary
Statement
Third party review
No

Clearances, product code GDF

Trailing 12 months

FDA records hold no clearances under product code GDF in the trailing twelve months.

FDA records show no clearances under product code GDF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260