CONVEEN(R) LEG-BAG (600 ML)— 510(k) K871643

Name: FDA 510(k) clearance K871643
Creator: U.S. Food and Drug Administration
Published: 1987-06-10

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K871643 for CONVEEN(R) LEG-BAG (600 ML), Substantially Equivalent on 1987-06-10. Applicant: Coloplast A/S. Device class: 2.

Clearance details

Applicant: Coloplast A/S
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1987-04-27
Decision date: 1987-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Woth, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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.