GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007— 510(k) K000060

Substantially Equivalent

Senorx, Inc.

FDA 510(k) clearance K000060 for GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007, Substantially Equivalent on 2000-03-27. Applicant: Senorx, Inc..

Clearance details

Applicant: Senorx, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2000-01-10
Decision date: 2000-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.