PHARMA-PLAST URIDROP-URIDOME— 510(k) K843478

Substantially Equivalent

Zimmar Consulting , Ltd.

FDA 510(k) clearance K843478 for PHARMA-PLAST URIDROP-URIDOME, Substantially Equivalent on 1984-12-05. Applicant: Zimmar Consulting , Ltd..

Clearance details

Applicant: Zimmar Consulting , Ltd.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1984-09-06
Decision date: 1984-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.