Cleared Traditional

K253846 - Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02)

Also marketed or referenced as:
Disposable Sterile Steep Pulse Probe (NPA-DJ01) Probe connection line (NPA-LX-02)

K253846 is an FDA 510(k) clearance for Steep Pulse Ablation Instrument (includ..., manufactured by Hangzhou Ruidi Biotechnology , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OAB cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K253846 · Hangzhou Ruidi Biotechnology , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
253d
Days
Class 2
Risk

K253846 is an FDA 510(k) clearance for the Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Pro.... Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Hangzhou Ruidi Biotechnology , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 12, 2026 after a review of 253 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 Hangzhou Ruidi Biotechnology , Ltd. devices

FDA 510(k) Submission Details - K253846

510(k) Number K253846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2025
Decision Date August 12, 2026
Days to Decision 253 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
138d slower than avg
Panel avg: 115d · This submission: 253d
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 Consultant

Beijing Tigermed-Jyton Co., Ltd.
Xueping Deng

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 - OAB Low Energy Direct Current Thermal Ablation System

All 11
Devices cleared under the same product code (OAB) and FDA review panel - the closest regulatory comparables to K253846.
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K233884 · Galvanize Therapeutics, Inc. · May 2024
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K240297 · Us Medical Innovations, LLC · May 2024