LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))— 510(k) K232615

Substantially Equivalent

Devicor Medical Products, Inc.

FDA 510(k) clearance K232615 for LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)), Substantially Equivalent on 2024-01-12. Applicant: Devicor Medical Products, Inc..

Clearance details

Applicant: Devicor Medical Products, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2023-08-28
Decision date: 2024-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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.