GDY · Class I · 21 CFR 878.4450

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

Leading manufacturers include Lorrex Health Products, Thantex Specialties, Inc. and Medical Perspectives Corp..

111
Total
111
Cleared
72d
Avg days
1977
Since
111 devices
97–111 of 111
Cleared Dec 11, 1980
OPRATEX ABDOMINAL PAD
K802798
Secol Co.
General & Plastic Surgery · 37d
Cleared Oct 10, 1980
STERILE TONSIL SPONGES
K802060
Medspec Corp.
General & Plastic Surgery · 46d
Cleared Aug 20, 1980
CONTAIN X-RAY DETECTABLE LAP SPONGE
K801768
The Buckeye Cellulose Corp.
General & Plastic Surgery · 23d
Cleared Mar 12, 1980
MEDSPEC PACKING GAUZE
K800281
Medspec Corp.
General & Plastic Surgery · 36d
Cleared Jan 28, 1980
STANFORD STERILE LAP SPONGES
K800102
Lukens Corp.
General & Plastic Surgery · 12d
Cleared Jan 11, 1980
STERILIZATION PROCESS/X-RAY DETECT. SPG
K792630
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 23d
Cleared Dec 20, 1979
STANFORD STERILE LAP SPONGES
K792471
Lukens Corp.
General & Plastic Surgery · 17d
Cleared Mar 26, 1979
GAUZE & COTTON SPONGES
K790389
Medtech Intl., Inc.
General & Plastic Surgery · 28d
Cleared Feb 16, 1979
LAP SPONGE
K782107
Carapace, Inc.
General & Plastic Surgery · 59d
Cleared Jan 17, 1979
SPONGES, STANFORD STERILE LAP
K790050
Stanford Professional Products
General & Plastic Surgery · 7d
Cleared Nov 15, 1978
LAPARATOMY SPONGE
K781818
Meden Medical Sales Division
General & Plastic Surgery · 19d
Cleared Jun 28, 1978
SOF-WICKLAP PAD
K780718
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 58d
Cleared Jun 14, 1978
ARTERIAL LINE KIT
K780871
Argon Medical Corp.
General & Plastic Surgery · 15d
Cleared Aug 19, 1977
LAPAROTOMY SPONGES, STERILE
K771395
Medline Industries, Inc.
General & Plastic Surgery · 22d
Cleared Aug 10, 1977
GREEN RADIOPAQUE IN SURG. SPONGES
K770924
Kendall Research Center
General & Plastic Surgery · 82d