Cleared Traditional

K193619 - Cry-Ac

K193619 is the FDA 510(k) clearance for Cry-Ac by Brymill Cryogenic Systems. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K193619 · Brymill Cryogenic Systems · General & Plastic Surgery device
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Mar 2020
Decision
90d
Days
Class 2
Risk

K193619 is an FDA 510(k) clearance for the Cry-Ac®, Cry-Ac-3®, Cry-Baby. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Brymill Cryogenic Systems (Ellington, US). The FDA issued a Cleared decision on March 25, 2020 after a review of 90 days - within the typical 510(k) review window.

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 Brymill Cryogenic Systems devices

Submission Details

510(k) Number K193619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2019
Decision Date March 25, 2020
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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

G&L Scientific, Inc.
Roshana Ahmed

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 80
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