EXI · Class I · 21 CFR 876.5250

FDA Product Code EXI: Device, Paste-on For Incontinence, Sterile

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

7
Total
7
Cleared
106d
Avg days
1992
Since

FDA 510(k) Cleared Device, Paste-on For Incontinence, Sterile Devices (Product Code EXI)

7 devices
1–7 of 7
Cleared Feb 25, 1997
HOLLISTER RETRACTED PENIS POUCH
K970443
Hollister, Inc.
Gastroenterology & Urology · 20d
Cleared Jun 23, 1993
HOLLISTER PREMIUM URINE COLLECTOR
K931277
Hollister, Inc.
Gastroenterology & Urology · 107d
Cleared Jun 22, 1993
CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION
K924755
Convatec, A Division of E.R. Squibb & Sons
Chemistry · 272d
Cleared Feb 05, 1992
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
K915246
Coloplast A/S
Gastroenterology & Urology · 82d
Cleared Jan 23, 1992
URIHESIVE STRIP
K915616
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 38d

About Product Code EXI - Regulatory Context