BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)— 510(k) K962425

Name: FDA 510(k) clearance K962425
Creator: U.S. Food and Drug Administration
Published: 1996-09-11

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K962425 for BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4), Substantially Equivalent on 1996-09-11. Applicant: Radi Medical Systems AB. Device class: 1.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1996-06-24
Decision date: 1996-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.