Mepiseal Soft Silicone Sealant

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

510(k) Number

K152741 ↗

FDA Product Code

OMP

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Molnlycke Health Care Us, LLC →

• What is the primary purpose of the Mepiseal Soft Silicone Sealant in wound care, and how does it improve dressing adherence?

  The Mepiseal Soft Silicone Sealant is designed to fill uneven or irregular periwound skin surfaces, helping it conform to complex anatomical areas. This improves dressing adherence by sealing gaps around wounds, preventing leakage and reducing the risk of premature dressing displacement—particularly useful when paired with negative pressure wound therapy (NPWT) systems.

• Is the Mepiseal Soft Silicone Sealant sterile, and how should it be handled before use?

  The Mepiseal Soft Silicone Sealant is supplied as a non-sterile device. Before use, it must be sterilized by the clinician or facility using an appropriate method (e.g., alcohol swab or sterile technique) to ensure clean application to the skin. Always follow facility protocols for sterilization and preparation.

• How is the sealant applied, and what type of applicator is included?

  The sealant is applied using a two-component applicator system, where the components are mixed and dispensed directly onto the skin before dressing application. This ensures precise placement and proper adhesion to uneven wound edges or anatomical contours.

• Is this device intended for single-use or reusable applications, and why?

  The Mepiseal Soft Silicone Sealant is intended for single-use only. This is standard practice for adhesive sealants to maintain sterility, prevent cross-contamination, and ensure optimal performance without degradation from repeated use or reprocessing.

• What regulatory pathway was followed for FDA clearance, and which medical specialty is it primarily associated with?

  The device received FDA 510(k) clearance (K152741) under the classification 21 CFR 878.4780, determined to be *substantially equivalent* to a predicate product. It is primarily associated with general and plastic surgery, as indicated by its advisory committee designation (SU) and medical specialty description.