Cleared Traditional

Claritag (K190747) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190747 · Dgi Technologies · General & Plastic Surgery device
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Oct 2019
Decision
223d
Days
Class 2
Risk

K190747 is an FDA 510(k) clearance for the Claritag. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Dgi Technologies (Lakewood, US). The FDA issued a Cleared decision on October 31, 2019 after a review of 223 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dgi Technologies devices

Submission Details

510(k) Number K190747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2019
Decision Date October 31, 2019
Days to Decision 223 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 115d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Health Policy Associates
Russ Olsen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 64
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K190747.
Cry-Ac®, Cry-Ac-3®, Cry-Baby
K193619 · Brymill Cryogenic Systems · Mar 2020
ERBECRYO 2 Cryosurgical Unit
K190651 · Erbe Elektromedizin GmbH · Jan 2020
IceSense 3, ProSense, MultiSense
K183213 · IceCure Medical , Ltd. · Dec 2019
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
K190194 · Pentax Medical, A Division of Pentax of America, Inc. · May 2019
CryoLab
K190407 · Cryoconcepts LP · Apr 2019
CryoTouch
K183601 · Cryoconcepts LP · Apr 2019