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Claritag Advanced

by Dgi Technologies 510(k)

Active United States

510(k) K222356

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222356 Date18 May 2023ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GEH
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Claritag Advanced is a unit cryosurgical accessory device used for medical procedures. It is designed for use in general and plastic surgery applications.

The device is supplied by Dgi Technologies and has received FDA 510(k) clearance with decision code SESE. It is a Class II medical device with product code GEH and is intended for single-use in clinical settings.

Other devices from Dgi Technologies

  • Claritag

    Class II

Questions

AI-generated answers, 23 Sep 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 Claritag Advanced device used for?

    The Claritag Advanced is a unit cryosurgical accessory device designed specifically for use in general and plastic surgery applications. It is intended to assist in medical procedures requiring cryosurgical techniques.

  • Is the Claritag Advanced reusable or single-use?

    The Claritag Advanced is intended for single-use in clinical settings. After use, the device should be properly disposed of according to medical waste protocols to ensure safety and prevent cross-contamination.

  • What regulatory approvals does the Claritag Advanced have?

    The Claritag Advanced has received FDA 510(k) clearance with decision code SESE, indicating it is substantially equivalent to predicate devices. It is classified as a Class II medical device with product code GEH and is authorized for use in general and plastic surgery applications.

  • How is the Claritag Advanced supplied?

    The Claritag Advanced is supplied by Dgi Technologies. The device comes ready for use in clinical settings, though specific packaging details or quantities per package are not specified in the available information.