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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 / April 2026 / K260197

510(k) cleared

Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)

Suzhou Shenyun Medical Equipment Co., Ltd. · Apr 8, 2026 · K260197

FDA cleared the Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) from Suzhou Shenyun Medical Equipment Co., Ltd. on Apr 8, 2026 under K260197, 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 Jan 22, 2026. The decision came 76 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Suzhou Shenyun Medical Equipment Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260197?

K260197 is the FDA 510(k) for Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B), submitted by Suzhou Shenyun Medical Equipment Co., Ltd.. FDA's decision date was Apr 8, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)?

Suzhou Shenyun Medical Equipment Co., Ltd., based in Suzhou, is the applicant of record for K260197.

How long did the K260197 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on Apr 8, 2026, 76 days later.

← All decisions in April 2026