Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches— 510(k) K193325

Substantially Equivalent

Prosys International, Ltd.

FDA 510(k) clearance K193325 for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches, Substantially Equivalent on 2020-03-13. Applicant: Prosys International, Ltd..

Clearance details

Applicant: Prosys International, Ltd.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2019-12-02
Decision date: 2020-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wimbledon, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.