# K083783: VF Liquigel

- Pathway: 510(k) (Traditional)
- Applicant: Coapt Systems, Inc.
- Decided: Sep 11, 2009 after 266 days
- Product code: MIX (System, Vocal Cord Medialization)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913882 (1992). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080956: Modification to VF Gel Plus, Coapt Systems, Inc. (2008) Summary page 2.

## Indications for use
The VF LiquiGel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF LiquiGel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF LiquiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Source page: https://510kreport.com/device/K083783
Methodology: https://510kreport.com/methodology