# K080956: Modification to VF Gel Plus

- Pathway: 510(k) (Special)
- Applicant: Coapt Systems, Inc.
- Decided: Apr 25, 2008 after 22 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: 7 generations back to K913882 (1992). 25 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071663: VF Gel Plus, Coapt Systems, Inc. (2008) Summary page 2.

## Most influential descendants
- K083783: VF Liquigel (2009), 0 descendants of its own
- K081816: Vocalis and Vocalis SM (2009), 0 descendants of its own
- K081815: Vocalis Gel (2009), 0 descendants of its own

## Indications for use
The VF Gel 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 Gel 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 Gel 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/K080956
Methodology: https://510kreport.com/methodology