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Tecnol Classic Cone Mask

by Tecnol New Jersey Wound Care, Inc.

510(k) K870056

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 NumberK870056 Date6 Feb 1987ClearedStatusActive

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  • Withdrawn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
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Tecnol Classic Cone Mask is a cone-shaped surgical mask designed for wound care applications. It is classified under the FDA product code FXX and serves as a protective barrier to maintain a sterile field during surgical procedures, particularly in general and plastic surgery settings. Constructed from plastic, it is intended to fit snugly over wounds or surgical sites to prevent contamination while allowing for controlled airflow and drainage.

This device is supplied as a single-use item and has received FDA 510(k) clearance under the traditional review pathway, with a decision date of February 6, 1987. It is intended for use in sterile environments, such as operating rooms or surgical suites, and must be handled and stored according to manufacturer guidelines to ensure sterility and functionality. The device is regulated under the FDA’s General, Plastic Surgery advisory committee and is not intended for MRI use. No additional sizes or variations are specified beyond the product name.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Tecnol Classic Cone Mask used for?

    The Tecnol Classic Cone Mask is designed as a protective barrier for wounds or surgical sites during general and plastic surgery. Its cone shape fits snugly over the site to block contamination while allowing controlled airflow and drainage, maintaining a sterile field in operating rooms or surgical suites.

  • Is the Tecnol Classic Cone Mask single-use or reusable?

    The Tecnol Classic Cone Mask is intended for single-use only. This ensures sterility and prevents cross-contamination between patients, adhering to best practices for surgical wound care.

  • How should the Tecnol Classic Cone Mask be stored?

    The device must be stored according to manufacturer guidelines to preserve sterility and functionality. Since it is single-use, it should be kept in its original packaging until immediately before use, away from direct sunlight, moisture, or extreme temperatures.

  • Can the Tecnol Classic Cone Mask be used in MRI environments?

    No, the Tecnol Classic Cone Mask is explicitly not intended for MRI use. Its plastic construction and design are optimized for surgical settings, not magnetic resonance imaging compatibility.

  • What regulatory pathway was followed for FDA clearance?

    The Tecnol Classic Cone Mask received FDA 510(k) clearance through the traditional review pathway, determined to be substantially equivalent to a predicate device. The decision was made by the FDA’s General, Plastic Surgery advisory committee on February 6, 1987.