# K123133: Barle Tissue Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions (Plymouth), Ltd.
- Decided: May 22, 2013 after 230 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: 3 generations back to P010002 (2002). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100284: Liquiband Ultima, Lut 003, Medlogic Global Limited (2010) Summary page 3.
- K100423: Dermabond NX Adhesive Model: DNX6, DNX12, ETHICON, Inc. (2010) Summary page 1.
- P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate), Closure Medical Corp. (1998) Summary page 1.
- K082993: Surgiseal Topical Skin Adhesive, Adhezion Biomedical (2008) Summary page 1.
- K101276: Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404, Chemence Medical Products, Inc. (2010) Summary page 1.

## Most influential descendants
- K132243: Barle Tissue Adhesive 2 (2013), 2 descendants of its own
- K151182: LiquiBand Exceed (2015), 1 descendant of its own
- K183570: LiquiBand Plus (2020), 0 descendants of its own

## Indications for use
Banle Tissue Adhesive topical skin adhesive is intended for topical applications 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. Banle Tissue Adhesive topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Source page: https://510kreport.com/device/K123133
Methodology: https://510kreport.com/methodology