Indermil Tissue Adhesive

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Indermil(Tm) Tissue Adhesive

Generic Name

Tissue adhesive for the topical approximation of skin

PMA Number

P010002 ↗

FDA Product Code

MPN

Device Class

Class II

Regulation

21 CFR Part 878.4010

Advisory Committee

General, Plastic Surgery

FDA Decision

APRL

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See all devices from Covidien Lp, Formerly Registered AS United States →

• What types of wounds is the Indermil Tissue Adhesive specifically designed to close, and how does it differ from traditional sutures in this context?

  The Indermil Tissue Adhesive is designed for sealing topical skin incisions, including laparoscopic incisions, as well as trauma-induced lacerations in areas of low skin tension where the wound edges are clean, simple, and easily approximated. Unlike deep dermal sutures—which it is not meant to replace—this adhesive provides a secure closure for the skin surface, ensuring hemostasis and wound stability without penetrating deeper tissue layers. It is not intended for high-tension areas or complex wounds.

• Is the Indermil Tissue Adhesive reusable, or is it meant for single-use only? How should it be stored to maintain sterility?

  The Indermil Tissue Adhesive is explicitly labeled as a sterile, single-use product, meaning it should not be reused after one application. To preserve sterility and efficacy, storage must follow the manufacturer’s guidelines, which likely include keeping it in its original packaging, protected from contamination, and away from extreme temperatures or moisture until use.

• What sizes or models of the Indermil Tissue Adhesive are available, and how is it supplied for clinical use?

  The provided data does not specify exact sizes or model variations (e.g., tube sizes, applicator types, or adhesive volumes), but the adhesive is supplied as a ready-to-use product for surgical and trauma settings. It is classified under FDA PMA P010002 and falls under product code MPN (Medical Polymeric Non-Implantable), indicating it is likely packaged in sterile applicators or dispensers for direct clinical application.

• Can the Indermil Tissue Adhesive be used in conjunction with other closure methods, and if so, what are the key considerations?

  Yes, the Indermil Tissue Adhesive may be used alongside deep dermal sutures but is not intended to replace them. The adhesive is specifically for topical skin approximation in low-tension areas with clean, simple wounds. Its use is supplementary to ensure hemostasis and wound stability on the skin surface, not a standalone solution for deeper tissue closure.

• What regulatory pathway does the Indermil Tissue Adhesive follow, and what does this mean for clinicians or facilities considering its use?

  The Indermil Tissue Adhesive is regulated under FDA Premarket Approval (PMA P010002), meaning it has undergone rigorous review by the FDA to demonstrate safety and effectiveness for its intended use. Clinicians or facilities should confirm compliance with the manufacturer’s storage, handling, and application instructions to ensure proper use, as this pathway ensures the device meets strict performance standards before market authorization.