Cleared Traditional

K240376 - Electroporation System (N3000)

K240376 is an FDA 510(k) clearance for Electroporation System (N3000), manufactured by Surgnova Healthcare Technologies (Zhejiang) 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 240-day FDA review.

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

FDA 510(k) Submission Details - K240376

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
125d slower than avg
Panel avg: 115d · This submission: 240d
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 K240376.
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