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FDA 510(k)

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))

K-Number: K232615 · 2024-01-12

ApplicantDevicor Medical Products, Inc.
Decision Date2024-01-12
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) is a medical device manufactured by Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2024-01-12 under approval number K232615. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))?

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by Devicor Medical Products, Inc.. The 510(k) number is K232615.

When was LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) approved by the FDA?

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) received FDA 510(k) clearance on 2024-01-12, under approval number K232615.

What company makes LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))?

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) is manufactured by Devicor Medical Products, Inc..

What is the FDA product code for LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))?

The FDA product code for LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) is NEU.

Related Clinical Trials

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Other Devices by Devicor Medical Products, Inc.

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Related Devices (Code: NEU)

K152510UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. K171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. K170026Radiopaque Tissue MarkerViscus Biologics, LLC K170905Star Tissue MarkerScion Medical Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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