EXJ · Class I · 21 CFR 876.5250

FDA Product Code EXJ: Device, Incontinence, Urosheath Type, Sterile

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

22
Total
22
Cleared
102d
Avg days
1977
Since

FDA 510(k) Cleared Device, Incontinence, Urosheath Type, Sterile Devices (Product Code EXJ)

22 devices
1–22 of 22
Cleared Oct 25, 1996
PROSYS SAMEC LA
K963265
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 66d
Cleared Sep 16, 1996
SELF RETAINING MALE EXTERNAL URINARY CATHETER
K962900
Hollister, Inc.
Gastroenterology & Urology · 53d
Cleared Jul 06, 1995
CLEAR ADVANTAGE II
K945628
Mentor Corp.
Gastroenterology & Urology · 232d
Cleared May 12, 1995
PROSYS URIHESIVE SYSTEM LA
K951530
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 39d
Cleared Mar 23, 1995
PROSYS URIHESICE SYSTEM NL
K950690
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 37d
Cleared Feb 13, 1995
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
K946243
Coloplast A/S
Gastroenterology & Urology · 53d
Cleared Jun 02, 1994
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
K940269
Hollister, Inc.
Gastroenterology & Urology · 132d
Cleared Sep 23, 1992
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
K924407
Coloplast A/S
Gastroenterology & Urology · 29d
Cleared Oct 04, 1991
SILICONE MALE EXTERNAL CATHETER
K913524
Mentor Corp.
Gastroenterology & Urology · 57d
Cleared Nov 28, 1977
CATHETER, DISP., EXTERNAL, MALE
K772144
Medline Industries, Inc.
Gastroenterology & Urology · 13d

About Product Code EXJ - Regulatory Context