# K020024: Caris Minitome Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Artemis Medical, Inc.
- Decided: Apr 3, 2002 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
Longest line of descent: 3 generations back to K871390 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983296: Auto Suture Abbi System, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.
- K963825: Auto Suture* Abbi* System, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.
- K993936: 15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy Device, Imagyn Surgical (1999) Summary page 1.
- K970565: Mammotome Biopsy Probe and Housing (Mammotome), Biopsys Medical, Inc. (1997) Summary page 1.
- K003297: Mammotome Hand Held Probe, Model MHH8, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.
- K003190: EN Bloc Biopsy System, Neothermia Corp. (2001) Summary page 1.
- K003528: Sanarus Core Tissue Biopsy System, Endocare, Inc. (2001) Summary page 1.

## Indications for use
The Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The extent of 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 its 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/K020024
Methodology: https://510kreport.com/methodology