510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864193Substantially Equivalent

Gilbaugh Aspirating Biopsy Syringe/needle/gun

Gaw, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864193 is the FDA 510(k) clearance record for GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN, a class I device, cleared for Gaw, Inc. on under FDA product code GDM (Needle, Aspiration And Injection, Reusable). FDA records list one 510(k) clearance for Gaw, Inc. As of , FDA records show no recalls naming K864193.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GDM Needle, Aspiration And Injection, Reusable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Gaw, Inc. 9155 SW Carnes Rd., #422, Portland OR
Third party review
No

Clearances, product code GDM

Trailing 12 months

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

FDA records show no clearances under product code GDM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDM, 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