PLEURA BIOPSY DEVICE— 510(k) K901995

Substantially Equivalent

Mill-Rose Laboratory

FDA 510(k) clearance K901995 for PLEURA BIOPSY DEVICE, Substantially Equivalent on 1990-07-10. Applicant: Mill-Rose Laboratory.

Clearance details

Applicant: Mill-Rose Laboratory
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1990-05-02
Decision date: 1990-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.