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Surgical Drapes

by Mallinckrodt Group, Inc.

510(k) K943122

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 NumberK943122 Date7 Sep 1994ClearedStatusActive

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  • Withdrawn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.

The Surgical Drapes are sterile, disposable barrier materials designed to isolate the surgical field from contamination during operative procedures. They are classified as surgical drapes under FDA nomenclature (Product Code KKX) and are intended to maintain aseptic conditions by covering the patient and surrounding areas.

These drapes are supplied in sterile packaging for single-use only and are regulated under FDA 510(k) clearance (K943122), classified as substantially equivalent to a predicate device. They are intended for use in surgical settings and must be handled according to sterile technique. No additional regulatory status beyond the stated 510(k) clearance is implied.

Other devices from Mallinckrodt Group, Inc.

See all devices from Mallinckrodt Group, Inc. →

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 surgical drapes reusable or intended for single-use only?

    These surgical drapes are designed for single-use only and come in sterile packaging. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and the integrity of the barrier against contamination during surgical procedures.

  • What sizes or models of surgical drapes are available?

    The provided data does not specify exact sizes or model variations of the surgical drapes. However, they are classified under FDA Product Code KKX, which typically includes a range of standard sizes for general surgical use. For precise sizing options, it would be best to consult the manufacturer’s product catalog or technical documentation.

  • How should these drapes be stored to maintain sterility?

    Since these drapes are sterile and supplied in sterile packaging, they should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. The packaging should remain intact until use to preserve sterility, and they should be handled using sterile technique before application.

  • What is the intended use of these surgical drapes in a clinical setting?

    These drapes are sterile barrier materials intended to isolate the surgical field from contamination during operative procedures. They cover the patient and surrounding areas to maintain aseptic conditions, ensuring a clean environment for surgery. They are not intended for any specific medical condition but are a standard part of surgical preparation.