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Acu-Derm Transparent Incise Drape

FDA 510(k)

Class II (US FDA 510(k))

510(k) K841735

by Acme United Corp.

Identifiers

510(k) Number
K841735 FDA 510(k)
FDA Product Code
KKX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4370 FDA 510(k)
Regulation Number
878.4370 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Acu-Derm Transparent Incise Drape is a sterile, transparent surgical drape designed to maintain a clean field during incisions. It is classified under the FDA product code KKX and serves as a barrier to protect the surgical site from contamination while allowing visibility of the operative area. Constructed to adhere to skin and surgical incisions, it helps minimize microbial ingress during procedures.

This drape is supplied sterile and intended for single-use in surgical settings, including general and plastic surgery. It is non-magnetic and MRI-safe, ensuring compatibility with magnetic resonance imaging environments. The device is regulated under FDA 510(k) clearance (K841735) and is categorized as a Class II medical device. Storage instructions and additional specifications are detailed in the manufacturer’s accompanying documentation.

Frequently asked questions

What is the Acu-Derm Transparent Incise Drape used for?

The Acu-Derm Transparent Incise Drape is designed to create a sterile barrier over surgical incision sites during procedures like general and plastic surgery. Its transparency allows surgeons to visualize the operative area while preventing microbial contamination from entering the wound. This makes it ideal for maintaining a clean field during procedures where visibility and sterility are critical.

Is the drape single-use or reusable?

This drape is intended for single-use only. It is supplied sterile to ensure contamination control during surgery, and reuse could compromise sterility and patient safety. Always follow the manufacturer’s instructions for proper disposal after one use.

Can this drape be used in MRI environments?

Yes, the Acu-Derm Transparent Incise Drape is non-magnetic and MRI-safe, meaning it can be used in magnetic resonance imaging environments without interfering with scans. This makes it suitable for procedures where MRI compatibility is required.

How does the drape adhere to the surgical site?

The drape is designed to adhere directly to the skin and incision site, creating a secure barrier that minimizes microbial ingress. This adhesion helps maintain a sterile field while allowing clear visibility of the operative area, reducing the risk of contamination during surgery.

Where should the drape be stored before use?

Storage instructions are detailed in the manufacturer’s accompanying documentation, but generally, sterile surgical drapes like this should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure the packaging remains intact until immediate use to maintain sterility.

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. Sources consulted: ACU-DERM TRANSPARENT INCISE DRAPE (K841735) — FDA 510(k) | Innolitics, Acu-derm Transparent Incise Drape - Beudamed, PDF K841735 - Acu-derm Transparent Incise Drape, Home - Acme United Corporation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acme United Corp.

Sources (1)

  • FDA 510(k) K841735 24 fields · synced Oct 1, 2026