Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MammoSTAR Biopsy Site Identifier

K-Number: K251748 · 2025-07-23

ApplicantCarbon Medical Technologies, Inc.
Decision Date2025-07-23
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MammoSTAR Biopsy Site Identifier is a medical device manufactured by Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-07-23 under approval number K251748. 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 MammoSTAR Biopsy Site Identifier?

MammoSTAR Biopsy Site Identifier is a medical device that received FDA 510(k) clearance on 2025-07-23. It is manufactured by Carbon Medical Technologies, Inc.. The 510(k) number is K251748.

When was MammoSTAR Biopsy Site Identifier approved by the FDA?

MammoSTAR Biopsy Site Identifier received FDA 510(k) clearance on 2025-07-23, under approval number K251748.

What company makes MammoSTAR Biopsy Site Identifier?

MammoSTAR Biopsy Site Identifier is manufactured by Carbon Medical Technologies, Inc..

What is the FDA product code for MammoSTAR Biopsy Site Identifier?

The FDA product code for MammoSTAR Biopsy Site Identifier is NEU.

Other Devices by Carbon Medical Technologies, Inc.

K172227Endoscopic Injection Needle K211590Fiducial Marker K253598InjecSURE Injection System PMA P980053AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

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.

↑