# K131947: Provox Vega Puncture Set

- Pathway: 510(k) (Traditional)
- Applicant: Atos Medical AB
- Decided: Oct 18, 2013 after 113 days
- Product code: EWL (Prosthesis, Laryngeal (Taub))
- Device class: 2
- Regulation: 21 CFR 874.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971244 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090455: Provox Vega, Model 8130-8135, Atos Medical AB (2009) Summary page 1.
- K940638: Provox (TM) Voice Prosthesis, Atos Medical AB (1994) Summary page 1.

## Most influential descendants
- K240763: FirstFit Surgical Kit (2024), 0 descendants of its own

## Indications for use
Provox® VegaTM Puncture Set is a device for performing a primary or secondary tracheo-esophageal (TE) puncture in laryngectomized patients, with integrated placement of a Provox Vega voice prosthesis. The Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ. Environments of use include; - Provox Vega Puncture Set - Hospitals - Provox Vega Voice Prosthesis - Hospitals, sub-acute care institutions and home.

Source page: https://510kreport.com/device/K131947
Methodology: https://510kreport.com/methodology