510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253846Substantially Equivalent

Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)

Hangzhou Ruidi Biotechnology, Ltd., Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253846 is the FDA 510(k) clearance record for Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02), a class II device, cleared for Hangzhou Ruidi Biotechnology , Ltd. on under FDA product code OAB (Low Energy Direct Current Thermal Ablation System). FDA's definition for product code OAB reads: "Ablation of soft tissue". FDA records list one 510(k) clearance for Hangzhou Ruidi Biotechnology , Ltd. As of , FDA records show no recalls naming K253846.

Clearance record

Decision date
Received
(253 days to decision)
Product code
OAB Low Energy Direct Current Thermal Ablation System
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Hangzhou Ruidi Biotechnology , Ltd. 8/F, 4th Bldg.,#2959 Yuhangtang Rd.,Cangqian St., Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAB

Trailing 12 months
3 clearances under product code OAB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OAB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260