Cleared Traditional

K240376 - Electroporation System (N3000) (FDA 510(k) Clearance)

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

K240376 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · General & Plastic Surgery device
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Oct 2024
Decision
240d
Days
Class 2
Risk

K240376 is an FDA 510(k) clearance for the Electroporation System (N3000). Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on October 4, 2024 after a review of 240 days - an extended review cycle.

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. 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 Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. devices

Submission Details

510(k) Number K240376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2024
Decision Date October 04, 2024
Days to Decision 240 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
126d slower than avg
Panel avg: 114d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (OAB) and FDA review panel - the closest regulatory comparables to K240376.
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