# K111959: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Feb 6, 2012 after 210 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 P050013 (2007). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P050013: Histoacryl and Histoacryl Blue Topical Skin Adhesive, Tissue Seal, LLC (2007) Summary page 2.

## Most influential descendants
- K121976: Aesculap Histoacryl Flexible Topical Skin Adhesive (2013), 1 descendant of its own
- K140343: Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with Applicator Tip (2014), 0 descendants of its own

## Indications for use
Histoacryl and Histoacryl Blue 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 and Histoacryl Blue may be used in conjunction with, but not in place of, dermal sutures.

Source page: https://510kreport.com/device/K111959
Methodology: https://510kreport.com/methodology