# K190378: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix

- Pathway: 510(k) (Traditional)
- Applicant: Bioncise NV
- Decided: May 24, 2019 after 94 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 K033700 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080095: Coramate/Spirotome System, Medinvents (2008) Summary page 4.

## Indications for use
The Spirotome Endo is a family of large core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue. The Spirotome Endo is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities of the internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.

Source page: https://510kreport.com/device/K190378
Methodology: https://510kreport.com/methodology