# K223866: Carevix™ Suction Cervical Stabilizer

- Pathway: 510(k) (Special)
- Applicant: Aspivix SA
- Decided: Jan 25, 2023 after 33 days
- Product code: HDC (Tenaculum, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890379 (1989). 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)
- K203820: ASPIVIX  v1.1 Cervical Suction Tenaculum, Aspivix SA (2021) Summary page 4.

## Indications for use
The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.

Source page: https://510kreport.com/device/K223866
Methodology: https://510kreport.com/methodology