MEDIFLEX DRAINAGE BAG— 510(k) K843126

Name: FDA 510(k) clearance K843126
Creator: U.S. Food and Drug Administration
Published: 1984-10-04

Substantially Equivalent

Mediflex Intl.

FDA 510(k) clearance K843126 for MEDIFLEX DRAINAGE BAG, Substantially Equivalent on 1984-10-04. Applicant: Mediflex Intl.. Device class: 2.

Clearance details

Applicant: Mediflex Intl.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1984-08-10
Decision date: 1984-10-04
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 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.