# K030472: Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Oct 9, 2003 after 239 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
Longest line of descent: 1 generation back to K991980 (1999). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992813: 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound, Housing Stereotactic,Housing, Ult, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K991980: Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch,, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.

## Most influential descendants
- K093512: Encor Breast Biopsy System (2009), 5 descendants of its own
- K111100: Encor Enspire Breast Biopsy System (2011), 3 descendants of its own
- K233220: EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) (2023), 2 descendants of its own
- K252681: EnCor EnCompass™ Breast Biopsy and Tissue Removal System (2025), 1 descendant of its own
- K262571: EnCor EnCompass™ Breast Biopsy and Tissue Removal System (2026), 0 descendants of its own

## Indications for use
The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Source page: https://510kreport.com/device/K030472
Methodology: https://510kreport.com/methodology