# K992813: 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound, Housing Stereotactic,Housing, Ult

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Nov 18, 1999 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.
9 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)
- None. The FDA summary names its predicate without a number.
- (no number) Mammotome® Biopsy System: 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
- 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

## Indications for use
The Mammotome® Biopsy System is indicated to provide breast 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 extent of a histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the 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.

Source page: https://510kreport.com/device/K992813
Methodology: https://510kreport.com/methodology