Histoacryl and Histoacryl Blue Topical Skin Adhesive
PMA P050013
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP050013 | Date16 Feb 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Tissue adhesive for the topical approximation of skin
- PMA Number
- FDA Product Code
- MPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4010
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
Histoacryl and Histoacryl Blue Topical Skin Adhesive is a tissue adhesive for the topical approximation of skin, classified as a Class II medical device. It is designed to hold closed easily approximated skin edges of minimum-tension wounds, including clean surgical incisions and thoroughly cleansed trauma-induced lacerations. The adhesive polymerizes upon contact with tissue fluid to achieve wound closure.
The product is supplied as a single-use topical adhesive, available in translucent and blue variants for visual application control. It is intended for use in general and plastic surgery settings, with approval under an FDA Premarket Approval (PMA). Storage and handling must comply with manufacturer guidelines to maintain sterility and efficacy. The blue variant aids in assessing the quantity applied during procedures.
Questions
AI-generated answers, 18 Sep 2026
What types of wounds is Histoacryl Topical Skin Adhesive approved to close, and how does it differ from sutures?
Histoacryl is approved for closing easily approximated skin edges of minimum-tension wounds, including clean surgical incisions and thoroughly cleansed trauma-induced lacerations. Unlike dermal sutures, it is not intended as a replacement but may be used in conjunction with sutures for added support. It polymerizes upon contact with tissue fluid to achieve wound closure, making it suitable for low-stress areas where precise approximation is achievable.
Is Histoacryl available in different colors, and if so, what purpose does the blue variant serve?
Yes, Histoacryl is supplied in two variants: a translucent version and a blue-tinted version. The blue variant helps clinicians visually assess the quantity applied during procedures, ensuring accurate application without excess or deficiency. Both are single-use and intended for topical skin approximation.
How should Histoacryl be stored, and is sterility maintained for reuse?
Histoacryl is a single-use topical adhesive, meaning each application requires a new unit. Storage must comply with the manufacturer’s guidelines to maintain sterility and efficacy. Improper handling could compromise its performance, so adherence to packaging instructions is critical.
What surgical specialties is this adhesive approved for, and where is it manufactured?
Histoacryl is approved for use in general and plastic surgery settings, as indicated by its advisory committee classification. It is manufactured by Tissue Seal, LLC, located at 5643 Plymouth Rd., Ann Arbor, MI 48105.