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

Name: FDA 510(k) clearance K000060
Creator: U.S. Food and Drug Administration
Published: 2000-03-27

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.. Device class: 2.

Clearance details

Applicant: Senorx, Inc.
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
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

Download summary PDF View on FDA.gov ↗

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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.