INDWELLING FECAL MANAGEMENT SYSTEM— 510(k) K012113

Name: FDA 510(k) clearance K012113
Creator: U.S. Food and Drug Administration
Published: 2002-05-03

Substantially Equivalent

Bowel Management Systems, LLC

FDA 510(k) clearance K012113 for INDWELLING FECAL MANAGEMENT SYSTEM, Substantially Equivalent on 2002-05-03. Applicant: Bowel Management Systems, LLC. Device class: 2.

Clearance details

Applicant: Bowel Management Systems, LLC
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-06
Decision date: 2002-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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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.