510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823274Substantially Equivalent

Uni-Tip Colostomy Irrigation Cone

Howmedica Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823274 is the FDA 510(k) clearance record for UNI-TIP COLOSTOMY IRRIGATION CONE, a class II device, cleared for Howmedica Corp. on under FDA product code EXD (Irrigator, Ostomy). FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K823274.

Clearance record

Decision date
Received
(34 days to decision)
Product code
EXD Irrigator, Ostomy
Regulation
21 CFR 876.5895
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Howmedica Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EXD

Trailing 12 months

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

FDA records show no clearances under product code EXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EXD, 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