510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832299Substantially Equivalent

Visi-Flow Irrigator

Convatec, A Division of E.R. Squibb & Sons, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832299 is the FDA 510(k) clearance record for VISI-FLOW IRRIGATOR, a class II device, cleared for Convatec, A Division of E.R. Squibb & Sons on under FDA product code EXD (Irrigator, Ostomy). FDA records list 84 510(k) clearances for Convatec, A Division of E.R. Squibb & Sons, from to . As of , FDA records show no recalls naming K832299.

Clearance record

Decision date
Received
(44 days to decision)
Product code
EXD Irrigator, Ostomy
Regulation
21 CFR 876.5895
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Convatec, A Division of E.R. Squibb & Sons 4221 Richmond Rd., NW, Walker MI
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