Mammotome AutoCore™ Single Insertion Core Biopsy System (K243095)
Description
Mammotome AutoCore™ Single Insertion Core Biopsy System by Devicor Medical Products, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243095
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. Mammotome AutoCore™ Single Insertion Core Biopsy System (K243095) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141552 | ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS | Care Fusion | 2014 |
Trace the full predicate network for K243095
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.