510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K791146Substantially Equivalent

Colo-Tape

Suburban Ostomy Supply Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791146 is the FDA 510(k) clearance record for COLO-TAPE, a class I device, cleared for Suburban Ostomy Supply Co., Inc. on under FDA product code EZR (Cement, Stomal Appliance, Ostomy). FDA records list one 510(k) clearance for Suburban Ostomy Supply Co., Inc. As of , FDA records show no recalls naming K791146.

Clearance record

Decision date
Received
(42 days to decision)
Product code
EZR Cement, Stomal Appliance, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Suburban Ostomy Supply Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EZR

Trailing 12 months

FDA records hold no clearances under product code EZR in the trailing twelve months.

FDA records show no clearances under product code EZR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260