GDY · Class I · 21 CFR 878.4450

FDA Product Code GDY: Gauze/sponge, Internal, X-ray Detectable

Leading manufacturers include Procter & Gamble Mfg. Co., American Medical Disposable, Inc. and Medline Industries, Inc..

111
Total
111
Cleared
72d
Avg days
1977
Since

FDA 510(k) Cleared Gauze/sponge, Internal, X-ray Detectable Devices (Product Code GDY)

111 devices
1–24 of 111
Cleared Feb 22, 1996
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599
Stryker Corp.
General & Plastic Surgery · 76d
Cleared Feb 07, 1994
STERILE LAPAROTOMY SPONGES
K934971
Medsurg Industries, Inc.
General & Plastic Surgery · 112d
Cleared Dec 09, 1988
QUALTEX NEUROLOK SURGICAL SPONGE
K884790
Deroyal Industries, Inc.
General & Plastic Surgery · 24d
Cleared Feb 23, 1983
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201
American Medical Disposable, Inc.
General & Plastic Surgery · 34d
Cleared Feb 23, 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202
American Medical Disposable, Inc.
General & Plastic Surgery · 34d
Cleared Oct 20, 1981
X-RAY DETECTABLE LAP SPONGES
K812651
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 33d
Cleared Jan 15, 1981
GAUZE SPONGES
K803188
Abco Dealers, Inc.
General & Plastic Surgery · 30d
Cleared Jan 11, 1980
STERILIZATION PROCESS/X-RAY DETECT. SPG
K792630
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 23d
Cleared Jun 28, 1978
SOF-WICKLAP PAD
K780718
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 58d
Cleared Aug 19, 1977
LAPAROTOMY SPONGES, STERILE
K771395
Medline Industries, Inc.
General & Plastic Surgery · 22d

About Product Code GDY - Regulatory Context