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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 / January 2026 / K251923

510(k) cleared

Medical Shaver System (Morcellator) (YSB-IIIA)

Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · Jan 29, 2026 · K251923

FDA cleared the Medical Shaver System (Morcellator) (YSB-IIIA) from Hangzhou Hawk Optical Electronic Instruments Co., Ltd. on Jan 29, 2026 under K251923, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 23, 2025. The decision came 220 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 Hawk Optical Electronic Instruments Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251923?

K251923 is the FDA 510(k) for Medical Shaver System (Morcellator) (YSB-IIIA), submitted by Hangzhou Hawk Optical Electronic Instruments Co., Ltd.. FDA's decision date was Jan 29, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Medical Shaver System (Morcellator) (YSB-IIIA)?

Hangzhou Hawk Optical Electronic Instruments Co., Ltd., based in Hangzhou, is the applicant of record for K251923.

How long did the K251923 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Jan 29, 2026, 220 days later.

← All decisions in January 2026