Flexi-Seal PROTECT Fecal Management System— 510(k) K162906

Substantially Equivalent

Convatec

FDA 510(k) clearance K162906 for Flexi-Seal PROTECT Fecal Management System, Substantially Equivalent on 2017-03-07. Applicant: Convatec.

Clearance details

Applicant: Convatec
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2016-10-17
Decision date: 2017-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deeside, 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.