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
K882708Substantially Equivalent

Gauze Sponge, X-Ray Detectable

Bioseal, Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882708 is the FDA 510(k) clearance record for GAUZE SPONGE, X-RAY DETECTABLE, a class I device, cleared for Bioseal on under FDA product code GDY (Gauze/Sponge, Internal, X-Ray Detectable). FDA records list 10 510(k) clearances for Bioseal, from to . As of , FDA records show 4 recalls naming K882708.

Clearance record

Decision date
Received
(37 days to decision)
Product code
GDY Gauze/Sponge, Internal, X-Ray Detectable
Regulation
21 CFR 878.4450
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Bioseal 350 N. Palm, Brea CA
Third party review
No

Clearances, product code GDY

Trailing 12 months

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

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