Histoacryl and Histoacryl Blue - P050013
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Histoacryl® and Histoacryl® Blue Topical Skin Adhesive
PMA Applicant: Tissue Seal LLC
Address:5643 Plymouth Road, Ann Arbor , Michigan 48105
Approval Date: February 16, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050013a.pdf
What is it? The device is a glue similar to "Superglue" that is used to closed small skin cuts, lacerations (tears in skin), or surgical incisions (wounds from sharp objects such as a scalpel).
How does it work? It is applied by an applicator to the skin. Once it comes into contact with the skin, the glue hardens rapidly.
When is it used? Histoacryl topical skin adhesive is used to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl® may be used in conjunction with but not in place of dermal sutures.
What will it accomplish? The device will hold the edges of skin wounds together so the skin can heal.
When should it not be used? Histoacryl topical skin adhesive should not to be applied:
- below the skin;
- in areas with dense natural hair;
- near or on the eye;
- on areas where skin pulls tightly when moved such as the elbows, knees, or knuckles;
- to wounds that show evidence of infection or gangrene;
- to the skin of patients with known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process; and
- to the skin of patients with a known allergy to cyanoacrylate (a plastic), formaldehyde (a preservative) or the dye D&C Violet #2.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050013