DIENER RETRIEVAL DEVICES— 510(k) K950559

Substantially Equivalent

Mill-Rose Laboratory

FDA 510(k) clearance K950559 for DIENER RETRIEVAL DEVICES, Substantially Equivalent on 1995-02-16. Applicant: Mill-Rose Laboratory.

Clearance details

Applicant: Mill-Rose Laboratory
Product code: Code FCL
Advisory panel: Gastroenterology, Urology
Date received: 1995-02-08
Decision date: 1995-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

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Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.