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
K813494Substantially Equivalent

Waters Ileal Reservoir Catheter

Waters Instruments, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813494 is the FDA 510(k) clearance record for WATERS ILEAL RESERVOIR CATHETER, a class I device, cleared for Waters Instruments, Inc. on under FDA product code KPH (Catheter, Rectal For Continent Ileostomy). FDA records list 12 510(k) clearances for Waters Instruments, Inc., from to . As of , FDA records show no recalls naming K813494.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KPH Catheter, Rectal For Continent Ileostomy
Regulation
21 CFR 876.5030
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Waters Instruments, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KPH

Trailing 12 months

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

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