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General product information only, not medical advice. Wound-closure decisions belong to a licensed clinician.
Short answer
Exofin is a brand of liquid topical skin adhesive made by Chemence Medical Products. The FDA cleared Exofin High Viscosity Tissue Adhesive (510(k) K152476, decision date 9 February 2016) as a 2-octyl cyanoacrylate product for closing easily approximated skin edges. It is a topical device, and it is used with deep dermal sutures, not in place of them.
What Exofin is and what FDA cleared it for
The FDA 510(k) database lists K152476 as Exofin High Viscosity Tissue Adhesive from Chemence Medical Products, Inc. (Alpharetta, Georgia), product code MPN, classification name “Tissue Adhesive For The Topical Approximation Of Skin”, with the decision “Substantially Equivalent”. The cleared predicates were Derma+Flex QS (K101276) and Dermabond NX (K100423).
The FDA summary describes the product as a sterile, liquid topical skin adhesive with a monomeric 2-octyl cyanoacrylate formulation and a D&C Violet #2 colorant. It is supplied in a single-use aluminum collapsible tube. The summary describes the liquid as syrup-like in viscosity and states that it polymerizes within minutes.
The cleared indications, in plain terms
- Topical use only.
- Closing easily approximated skin edges of surgical incisions, including minimally invasive surgery incisions.
- Closing simple, cleaned traumatic lacerations.
- May be used with deep dermal sutures but not in place of them.
This page does not describe how to apply the product. Application belongs in the manufacturer’s instructions for use and clinical training.
Cyanoacrylate chemistry: 2-octyl versus n-butyl
Both products are cyanoacrylate tissue adhesives, but their FDA records name different monomers: 2-octyl cyanoacrylate for Exofin and n-butyl-2-cyanoacrylate for Histoacryl Flexible.
| Item | Exofin High Viscosity (K152476) | Histoacryl Flexible (K121976) |
|---|---|---|
| Applicant | Chemence Medical Products, Inc. | Aesculap, Inc. |
| FDA decision date | 9 February 2016 | 17 May 2013 |
| Monomer | 2-octyl cyanoacrylate | n-butyl-2-cyanoacrylate, with softener and stabilizer |
| Colorant | D&C Violet #2 | D&C Violet #2 |
| Packaging described by FDA | Single-use aluminum collapsible tube | 0.5 ml single-patient-use plastic ampoules, each sealed in a foil pouch |
| Product code and regulation | MPN | MPN, 21 CFR 878.4010 |
| Skin-edge indication | Easily approximated skin edges of surgical incisions and simple cleaned lacerations; with, not instead of, deep dermal sutures | Easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed lacerations; with, not instead of, deep dermal sutures |
Source: FDA 510(k) records K152476 and K121976, checked 30 October 2026. The table compares regulatory descriptions. It makes no claim that one product performs better than the other.
Topical versus internal adhesives: Class II and Class III
Under 21 CFR 878.4010, a tissue adhesive for topical approximation of skin is intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. It is a Class II device regulated with special controls. Tissue adhesives intended for non-topical uses, such as internal tissues or vessels, embolization or ophthalmic use, fall under paragraph (b) and are Class III devices that need premarket approval (eCFR, checked 30 October 2026).
The practical point is that a topical skin adhesive clearance does not extend to internal use. For background on the device category, see what is a medical device.
Liquiband, Histoacryl, Indermil and Glubran
People who search for Exofin often search these names too. They are separate branded products, each with its own FDA record or regulatory documentation and its own instructions for use. The specifications in this page belong to Exofin and to Histoacryl Flexible only, and should not be carried across to another brand.
Histoacryl
Histoacryl Flexible is the n-butyl comparison point in the table above. Its FDA record names Histoacryl and Histoacryl Blue (K111959) and Dermabond (P960052) as devices it is equivalent to.
Liquiband, Indermil and Glubran
Treat each as its own product. Confirm the intended use, composition and packaging from that product’s own label and instructions for use rather than from a comparison with Exofin.
Where it matters for labs, clinics and supply decisions
A supply team reading a label or instructions for use can check the points that the FDA records themselves treat as defining. These are questions to answer from the document, not recommendations.
- Which FDA product code and 510(k) number does the label or IFU reference?
- Does the stated indication limit use to topical closure of easily approximated skin edges?
- Does the IFU say the product may accompany deep dermal sutures but not replace them?
- Is the pack a single-use tube, an ampoule or another format?
- Which monomer does the formulation use, 2-octyl or n-butyl?
Related reading: wound dressings and butterfly closures cover other wound-covering and closure-assist products, and the wound care supply guide places adhesives among related supplies.
Common misunderstandings
A tissue adhesive is not a suture substitute
The cleared indication for both products above is easily approximated skin edges, and both statements say the adhesive may be used with deep dermal sutures but not in place of them. See what is a suture for how sutures differ from adjacent closure options.
Topical clearance is not clearance for internal use
Internal-tissue and vessel adhesives are a separate Class III category under 21 CFR 878.4010(b).
Brand names do not share a specification
Two products can both be cyanoacrylate tissue adhesives and still differ in monomer, packaging and cleared wording, as the table shows.
FAQ
What is Exofin?
Exofin is Chemence Medical Products’ liquid topical skin adhesive. The FDA cleared Exofin High Viscosity Tissue Adhesive under 510(k) K152476 on 9 February 2016.
What is Exofin made of?
The FDA summary describes a monomeric 2-octyl cyanoacrylate formulation with a D&C Violet #2 colorant.
Is Exofin the same as Histoacryl?
No. They are different products from different applicants. Histoacryl Flexible is described by the FDA as n-butyl-2-cyanoacrylate, while Exofin is 2-octyl cyanoacrylate. Both carry the same FDA product code, MPN.
Can Exofin replace sutures?
The cleared indication is for easily approximated skin edges, and the FDA summary says it may be used with deep dermal sutures but not in place of them.
Sources
- FDA 510(k) database, K152476, Exofin High Viscosity Tissue Adhesive, checked 30 October 2026.
- FDA 510(k) summary text for K152476, mirrored at https://fda.innolitics.com/device/K152476, checked 30 October 2026.
- FDA 510(k) summary text for K121976, Histoacryl Flexible, mirrored at https://fda.innolitics.com/device/K121976, checked 30 October 2026.
- eCFR, 21 CFR 878.4010, Tissue adhesive, checked 30 October 2026.
