# K991980: Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch,

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Aug 17, 1999 after 64 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.
22 later devices descend from it; 6 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mammotome® Biopsy Multi-Probe and Housing: named in the summary without a submission number
- (no number) Powered Suction Pump: named in the summary without a submission number
- (no number) Tubing Clamp and Tubing Accessory: named in the summary without a submission number
- (no number) Arm Clamp: named in the summary without a submission number

## Most influential descendants
- K030472: Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System (2003), 7 descendants of its own
- K093512: Encor Breast Biopsy System (2009), 5 descendants of its own
- K020047: Rubicor Breast Biopsy Device (2002), 5 descendants of its own
- K024089: Vacuflash Biopsy System (2003), 4 descendants of its own
- K023601: Rubicor Encapsule Breast Biopsy Device, Model 30086 (2002), 4 descendants of its own

## Indications for use
The Mammotome® Hand-Held System is indicated for use for incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal disease, and diffused tissue. The Mammotome® Hand-Held System is for diagnostic use only and is not indicated for therapeutic use.

Source page: https://510kreport.com/device/K991980
Methodology: https://510kreport.com/methodology