GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP— 510(k) K080698

Substantially Equivalent

Senorx, Inc.

FDA 510(k) clearance K080698 for GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP, Substantially Equivalent on 2008-03-31. Applicant: Senorx, Inc..

Clearance details

Applicant: Senorx, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2008-03-12
Decision date: 2008-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Aliso Viejo, CA, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.