# K203820: ASPIVIX  v1.1 Cervical Suction Tenaculum

- Pathway: 510(k) (Traditional)
- Applicant: Aspivix SA
- Decided: Aug 17, 2021 after 231 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: 3 generations back to K890379 (1989). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073182: Gyn Disposables Tenaculum 356T, Gyn-Disposables, Inc. (2007) Summary page 5.

## Most influential descendants
- K223866: Carevix™ Suction Cervical Stabilizer (2023), 0 descendants of its own

## Indications for use
The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.

Source page: https://510kreport.com/device/K203820
Methodology: https://510kreport.com/methodology