# K032847: Excisor Bioptome, Model 01-0004

- Pathway: 510(k) (Traditional)
- Applicant: Acueity, Inc.
- Decided: Sep 26, 2003 after 14 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 K954231 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954231: Augastroenterology-Urology Biopsy Instrument, Promex, Inc. (1995) Summary page 2.
- 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 2.

## Indications for use
The Acueity Excisor Bioptome is a multiple action biopsy system intended for obtaining a soft tissue breast biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.

Source page: https://510kreport.com/device/K032847
Methodology: https://510kreport.com/methodology