# K162352: derma+flex QS High Viscosity Tissue Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Chemence Medical, Inc.
- Decided: Dec 22, 2016 after 121 days
- Product code: MPN (Tissue Adhesive For The Topical Approximation Of Skin)
- Device class: 2
- Regulation: 21 CFR 878.4010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K101276 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101276: Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404, Chemence Medical Products, Inc. (2010) Summary page 4.

## Indications for use
derma+flex® QS ™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. derma+flex® QS ™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Source page: https://510kreport.com/device/K162352
Methodology: https://510kreport.com/methodology