# K060384: Coramate/Spirotome System

- Pathway: 510(k) (Traditional)
- Applicant: Medinvents
- Decided: Jul 13, 2006 after 149 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033700 (2004). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033700: Mammotome EX Hand Held System, Ethicon Endo-Surgery, Inc. (2004) Summary page 1.

## Most influential descendants
- K080095: Coramate/Spirotome System (2008), 1 descendant of its own
- K190378: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix (2019), 0 descendants of its own

## Recalls of this device
- Sep 26, 2014 · Class II · Z-0124-2015: MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to custo

## Indications for use
The Coramate/Spirotome system is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. The Coramate/Spirotome system is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the 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 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/K060384
Methodology: https://510kreport.com/methodology