Cleared Traditional

CryoThin™ Surgical System and Accessories (K231661) - FDA 510(k) Clearance

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

K231661 · Medinux (Tianjin) Technologies Co., Ltd. · General & Plastic Surgery device
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Nov 2023
Decision
173d
Days
Class 2
Risk

K231661 is an FDA 510(k) clearance for the CryoThin™ Surgical System and Accessories. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Medinux (Tianjin) Technologies Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on November 27, 2023 after a review of 173 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 Medinux (Tianjin) Technologies Co., Ltd. devices

Submission Details

510(k) Number K231661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2023
Decision Date November 27, 2023
Days to Decision 173 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
58d slower than avg
Panel avg: 115d · This submission: 173d
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 Peers - GEH Unit, Cryosurgical, Accessories

All 64
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K231661.
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