Cleared Traditional

K222001 - Irreversible Electroporation Ablation G...

K222001 is an FDA 510(k) clearance for Irreversible Electroporation Ablation G..., manufactured by Zhejiang Curaway Medical Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OAB cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K222001 · Zhejiang Curaway Medical Technology Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2023
Decision
336d
Days
Class 2
Risk

K222001 is an FDA 510(k) clearance for the Irreversible Electroporation Ablation Generator, Irreversible Electroporation.... Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Zhejiang Curaway Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 8, 2023 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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. Elevated predicate reliance profile. 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 Zhejiang Curaway Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K222001

510(k) Number K222001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2022
Decision Date June 08, 2023
Days to Decision 336 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 115d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAB Device Classification - Class 2, Special Controls

Product Code OAB Low Energy Direct Current Thermal Ablation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Ablation Of Soft Tissue
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 - OAB Low Energy Direct Current Thermal Ablation System

All 10
Devices cleared under the same product code (OAB) and FDA review panel - the closest regulatory comparables to K222001.
Electroporation System (N3000)
K240376 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 2024
INUMI™ Flex Needle
K233884 · Galvanize Therapeutics, Inc. · May 2024
Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
K240297 · Us Medical Innovations, LLC · May 2024
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
K212871 · Galvanize Therapeutics, Inc. · Jun 2022
NanoKnife System
K183385 · Angiodynamics · Jun 2019
NanoKnife System
K150089 · AngioDynamics, Inc. · Jun 2015