# K140343: Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with Applicator Tip

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 13, 2014 after 91 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 P050013 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111959: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive, Aesculap, Inc. (2012) Summary page 1.
- K121976: Aesculap Histoacryl Flexible Topical Skin Adhesive, Aesculap, Inc. (2013) Summary page 1.

## Indications for use
Histoacryl, Histoacryl Blue and Histoacryl Flexible topical skin adhesives are intended for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl, Histoacryl Blue and Histoacryl Flexible may be used in conjunction with, but not in place of, deep dermal sutures.

Source page: https://510kreport.com/device/K140343
Methodology: https://510kreport.com/methodology