EXB · Class I · 21 CFR 876.5900

FDA Product Code EXB: Collector, Ostomy

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

102
Total
102
Cleared
66d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 90d recently vs 66d historically

FDA 510(k) Cleared Collector, Ostomy Devices (Product Code EXB)

102 devices
1–24 of 102
Cleared Oct 06, 2025
Heylo™ System
K252140
Coloplast Corp.
Gastroenterology & Urology · 90d
Cleared Nov 16, 2018
SmartBag (SmartPouch)
K181643
11 Health Technologies Limited
Gastroenterology & Urology · 147d
Cleared Jul 13, 1988
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
K881636
Coloplast A/S
Gastroenterology & Urology · 90d
Cleared Oct 16, 1986
BARD IRYFIX(TM) STOMA CAP
K862631
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Jun 16, 1986
COLOPLAST CONVEX RING
K861070
Coloplast A/S
Gastroenterology & Urology · 88d
Cleared Apr 16, 1986
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 121d
Cleared Feb 04, 1986
DURAHESIVE WAFER WITH FLANGE
K855018
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 50d
Cleared Jun 24, 1985
STOMAHESIVE SKIN BARRIER STERILE
K851840
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 59d
Cleared Jun 12, 1985
JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT
K852297
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 14d
Cleared May 23, 1985
BARD PERISTOMAL PASTE
K851398
C.R. Bard, Inc.
Gastroenterology & Urology · 44d
Cleared Jan 08, 1985
COLOPLAST URO 2002 UROSTOMY SYSTEM
K844685
Coloplast A/S
Gastroenterology & Urology · 39d
Cleared Nov 29, 1984
UNITED SKIN BARRIERS
K844046
Howmedica Corp.
Gastroenterology & Urology · 43d
Cleared Nov 29, 1984
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
K844406
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 01, 1984
SUR-FIT IRRIGATION ADAPTER FACEPLATE
K842398
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 104d
Cleared May 02, 1984
COMFEEL PROTECTIVE FILM
K833567
Coloplast A/S
Gastroenterology & Urology · 203d
Cleared May 02, 1984
ACTIVE LIFE ONE-PIECE STOMA CAP
K840567
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 84d
Cleared May 02, 1984
ACTIVE LIFE ONE-PIECE CLOSED-END POUCH
K840568
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 84d
Cleared Apr 04, 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029
Howmedica Corp.
Gastroenterology & Urology · 23d
Cleared Apr 02, 1984
MC 2002 OSTOMY POUCHES & SKIN FLANGES
K840265
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Apr 02, 1984
FILTRODER FILTERS
K840267
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Apr 02, 1984
MC 2000 OSTOMY POUCHES
K840269
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Feb 04, 1984
BARD KARAYA GUM WASHERS
K834575
C.R. Bard, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 04, 1984
SUR-FIT UROSTOMY POUCH W/ACCUSEAL
K840166
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 19d
Cleared Jan 30, 1984
COMFEEL PASTE
K833565
Coloplast A/S
Gastroenterology & Urology · 110d

About Product Code EXB - Regulatory Context

510(k) Submission Activity

102 total 510(k) submissions under product code EXB since 1976, with 102 receiving FDA clearance (average review time: 66 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EXB Product Code

Recent submissions under EXB have taken an average of 90 days to reach a decision - up from 66 days historically. Manufacturers should account for longer review timelines in current project planning.

EXB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →