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Drapes, Disposable Surgical

by Marco Mfg.

510(k) K782051

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK782051 Date21 Mar 1979ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Disposable Surgical Drape, classified under the nomenclature for single-use protective barriers used in surgical settings. It is designed to maintain a sterile field during surgical procedures by isolating the operative site from contamination, ensuring patient and staff safety.

The drapes are intended for single-use only and are supplied in sterile packaging. They are regulated under FDA 510(k) clearance (K782051) and fall under the product code KKX, with a traditional review pathway. Storage and handling must adhere to sterile processing protocols to preserve integrity prior to use.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these drapes reusable or meant for single-use only, and why does that matter for surgical settings?

    These drapes are explicitly designed for single-use only, as stated in the device description. This matters because single-use surgical drapes prevent cross-contamination between patients and reduce the risk of introducing pathogens into the sterile field. Reusing them could compromise sterility, patient safety, and compliance with sterile processing protocols.

  • How should I store these drapes before use to ensure they remain sterile?

    The drapes must be stored in their sterile packaging until ready for use. Sterility is critical, so avoid opening the packaging prematurely or exposing the drapes to non-sterile environments. Adhering to sterile processing protocols—such as keeping them in a clean, dry area away from direct sunlight or moisture—will preserve their integrity until surgery.

  • What makes these drapes suitable for general and plastic surgery procedures?

    While the device is classified under the product code KKX (surgical drapes) and cleared via a traditional 510(k) review, its design aligns with general and plastic surgery needs by providing a sterile barrier to isolate the operative site. The classification and advisory committee reference (SU) suggest broad applicability, though specific surgical requirements (e.g., drape size, material) should still be verified for individual procedures.

  • Can I rely on these drapes for any surgical procedure, or are there specific types of surgeries they’re best suited for?

    The drapes are intended for general surgical use as a sterile barrier, but their suitability depends on the specific drape size, material, and design—details not provided here. They fall under the KKX product code, which covers disposable surgical drapes, but clinicians should confirm compatibility with their procedure (e.g., orthopedic vs. cosmetic plastic surgery) based on manufacturer guidelines or additional product specifications.