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
K193325Substantially Equivalent

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

Prosys International Ltd, Wimbledon, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193325 is the FDA 510(k) clearance record for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches, a class II device, cleared for Prosys International, Ltd. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list one 510(k) clearance for Prosys International, Ltd. As of , FDA records show no recalls naming K193325.

Clearance record

Decision date
Received
(102 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Prosys International, Ltd. Suite 303, Highland House, 165 The Broadway, Wimbledon, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNT

Trailing 12 months
2 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260