# P050013: Histoacryl and Histoacryl Blue Topical Skin Adhesive

- Pathway: PMA
- Applicant: Tissue Seal, LLC
- Decided: Feb 16, 2007 after 693 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.
3 later devices descend from it; 1 cites 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)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K111959: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive (2012), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/P050013
Methodology: https://510kreport.com/methodology