# K003297: Mammotome Hand Held Probe, Model MHH8

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Jan 18, 2001 after 90 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 8 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093068: Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105US (2009), 7 descendants of its own
- K093512: Encor Breast Biopsy System (2009), 5 descendants of its own
- K060413: Intact Breast Lesion Excision System and Advance (2006), 4 descendants of its own
- K024089: Vacuflash Biopsy System (2003), 4 descendants of its own
- K112411: Mammotome Elite Biopsy System (2012), 3 descendants of its own

Source page: https://510kreport.com/device/K003297
Methodology: https://510kreport.com/methodology