# K101276: Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404

- Pathway: 510(k) (Traditional)
- Applicant: Chemence Medical Products, Inc.
- Decided: Jul 28, 2010 after 83 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
No predicates in its family tree.
13 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) High Viscosity Dermabond Topical Skin Adhesive: named in the summary without a submission number

## Most influential descendants
- K130474: Surgiseal Topical Skin Adhesive (2013), 3 descendants of its own
- K123133: Barle Tissue Adhesive (2013), 3 descendants of its own
- K152476: Exofin High Viscosity Tissue Adhesive (2016), 2 descendants of its own
- K132243: Barle Tissue Adhesive 2 (2013), 2 descendants of its own
- K123936: Surgiseal Topical Skin Adhesive (2013), 2 descendants of its own

## 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 punctures 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/K101276
Methodology: https://510kreport.com/methodology