# K121976: Aesculap Histoacryl Flexible Topical Skin Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 17, 2013 after 316 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: 2 generations back to P050013 (2007). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 2.
- P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate), Closure Medical Corp. (1998) Summary page 2.

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

## Indications for use
Histoacryl Flexible topical skin adhesive Is 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 Flexible may be used in conjunction with, but not in place of, deep dermal sutures.

Source page: https://510kreport.com/device/K121976
Methodology: https://510kreport.com/methodology