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Innomed NPWT Silicone Foam Dressing

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202823

by Zhejiang Longterm Medical Technology Co., Ltd.

Identifiers

510(k) Number
K202823 FDA 510(k)
FDA Product Code
OMP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4780 FDA 510(k)
Regulation Number
878.4780 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Innomed NPWT Silicone Foam Dressing is a Negative Pressure Wound Therapy (NPWT) foam dressing designed to promote wound healing through controlled negative pressure. It is intended for use in acute and chronic wounds, including pressure ulcers, surgical wounds, and traumatic wounds, to enhance granulation tissue formation and reduce edema by maintaining a moist wound environment.

This single-use, sterile dressing is supplied as a foam pad integrated into a negative pressure wound therapy system. It is classified as a Class II medical device under FDA regulations (21 CFR 878.4780) and has received FDA 510(k) clearance and EU MDR authorization. The dressing is non-reusable and must be stored in a dry, clean environment prior to use, adhering to standard sterile wound care protocols.

Frequently asked questions

What types of wounds is the Innomed NPWT Silicone Foam Dressing designed to treat?

The Innomed NPWT Silicone Foam Dressing is specifically designed for acute and chronic wounds, including pressure ulcers, surgical wounds, and traumatic wounds. It promotes wound healing by enhancing granulation tissue formation and reducing edema through controlled negative pressure, while maintaining a moist wound environment.

Is the Innomed NPWT Silicone Foam Dressing reusable, or is it intended for single-use only?

The Innomed NPWT Silicone Foam Dressing is explicitly labeled as a single-use product. It must not be reused after application, as this could compromise sterility and effectiveness. Each dressing is sterile and intended for one-time use in a single patient.

How should the Innomed NPWT Silicone Foam Dressing be stored before use?

The dressing must be stored in a dry, clean environment prior to use. Since it is sterile, it should follow standard sterile wound care protocols to ensure integrity until application. Avoid exposure to moisture, extreme temperatures, or contamination.

What regulatory pathways has the Innomed NPWT Silicone Foam Dressing followed for approval?

The device has received FDA 510(k) clearance under the Traditional pathway, with a decision code of *SESE* (Substantially Equivalent) and classification as a Class II medical device (21 CFR 878.4780). It has also obtained EU MDR authorization, confirming compliance with European regulatory requirements.

What is the primary material composition of the Innomed NPWT Silicone Foam Dressing, and how does it function in NPWT?

The dressing is composed of silicone foam, which is integrated into a Negative Pressure Wound Therapy (NPWT) system. The silicone foam absorbs exudate while maintaining a moist wound environment, allowing controlled negative pressure to promote healing by reducing edema, enhancing blood flow, and stimulating granulation tissue formation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zhejiang Longterm Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K202823 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026