MammoSTAR Biopsy Site Identifier— 510(k) K251748
Substantially EquivalentCarbon Medical Technologies, Inc.
FDA 510(k) clearance K251748 for MammoSTAR Biopsy Site Identifier, Substantially Equivalent on 2025-07-23. Applicant: Carbon Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Carbon Medical Technologies, Inc.
- Product code
- Code NEU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
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More clearances from Carbon Medical Technologies, Inc.
view allAdverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
Source: openFDA MAUDE database, through . 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.