ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG— 510(k) K901320

Name: FDA 510(k) clearance K901320
Creator: U.S. Food and Drug Administration
Published: 1991-01-25

Substantially Equivalent

Ep Medical, Inc.

FDA 510(k) clearance K901320 for ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG, Substantially Equivalent on 1991-01-25. Applicant: Ep Medical, Inc.. Device class: 2.

Clearance details

Applicant: Ep Medical, Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-21
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kensington, CA, 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.