URINARY DRAINAGE BAG— 510(k) K935557

Substantially Equivalent

Puritas Health Care, Inc.

FDA 510(k) clearance K935557 for URINARY DRAINAGE BAG, Substantially Equivalent on 1994-03-07. Applicant: Puritas Health Care, Inc..

Clearance details

Applicant: Puritas Health Care, Inc.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-17
Decision date: 1994-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Milford, CT, US

Download summary PDF View on FDA.gov ↗

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.