MICROMARK CLIP— 510(k) K970817

Substantially Equivalent

Biopsys Medical, Inc.

FDA 510(k) clearance K970817 for MICROMARK CLIP, Substantially Equivalent on 1997-09-11. Applicant: Biopsys Medical, Inc..

Clearance details

Applicant: Biopsys Medical, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 1997-03-06
Decision date: 1997-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.