WATERS ILEOSTOMY VALVE— 510(k) K813585

Name: FDA 510(k) clearance K813585
Creator: U.S. Food and Drug Administration
Published: 1982-04-09

Substantially Equivalent

Waters Instruments, Inc.

FDA 510(k) clearance K813585 for WATERS ILEOSTOMY VALVE, Substantially Equivalent on 1982-04-09. Applicant: Waters Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Waters Instruments, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1981-12-28
Decision date: 1982-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.