Class Class II
MammoSTAR Biopsy Site Identifier (K251748)
Description
MammoSTAR Biopsy Site Identifier by Carbon Medical Technologies, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251748
Clearance Date2025-07-23
Clearance TypeTraditional
Product CodeNEU
Regulation Number878.4300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251748
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MammoSTAR Biopsy Site Identifier (K251748) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K100994 | PRELOADED TISSUE MARKER DEVICE | Carbon Medical Technologies, Inc. | 2010 |
Trace the full predicate network for K251748
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.