EXB · Class I · 21 CFR 876.5900

FDA Product Code EXB: Collector, Ostomy

Leading manufacturers include Hollister, Inc., Coloplast A/S and E. R. Squibb & Sons, Inc..

102
Total
102
Cleared
66d
Avg days
1976
Since
102 devices
97–102 of 102
Cleared Apr 15, 1977
STOMA BAG W/SKIN BARRIER SEAL RING
K770439
Hollister, Inc.
Gastroenterology & Urology · 39d
Cleared Feb 01, 1977
STOMA BAGS W/MICROPOROUS ADHESIVE
K770178
Hollister, Inc.
Gastroenterology & Urology · 6d
Cleared Dec 09, 1976
RECTAL TUBE DEVICE
K760886
Van Sickle Plastics Co.
Gastroenterology & Urology · 48d
Cleared Dec 02, 1976
BONGORT ILEOSTOMY POUCH
K760878
Howmedica Corp.
Gastroenterology & Urology · 42d
Cleared Nov 23, 1976
SILASTIC ILEAL RESERVOIR CATHETER
K760860
Dow Corning Corp. Healthcare Industries Materials
Gastroenterology & Urology · 36d
Cleared Oct 15, 1976
BONGORT SPECIAL ODORPROOF DRAIN
K760735
Howmedica Corp.
Gastroenterology & Urology · 17d