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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K253846

510(k) cleared

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. · Aug 12, 2026 · K253846

FDA cleared the 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) from Hangzhou Ruidi Biotechnology , Ltd. on Aug 12, 2026 under K253846, a traditional 510(k). The device falls under product code OAB, Low Energy Direct Current Thermal Ablation System, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 2, 2025. The decision came 253 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hangzhou Ruidi Biotechnology , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253846?

K253846 is the FDA 510(k) 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), submitted by Hangzhou Ruidi Biotechnology , Ltd.. FDA's decision date was Aug 12, 2026, under product code OAB (Low Energy Direct Current Thermal Ablation System).

Who makes the 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., based in Hangzhou, is the applicant of record for K253846.

How long did the K253846 review take?

FDA received the submission on Dec 2, 2025 and issued its decision on Aug 12, 2026, 253 days later.

← All decisions in August 2026