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FDA 510(k)

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

K-Number: K260197 · 2026-04-08

ApplicantSuzhou Shenyun Medical Equipment Co., Ltd.
Decision Date2026-04-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) is a medical device manufactured by Suzhou Shenyun Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-04-08 under approval number K260197. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)?

Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) is a medical device that received FDA 510(k) clearance on 2026-04-08. It is manufactured by Suzhou Shenyun Medical Equipment Co., Ltd.. The 510(k) number is K260197.

When was Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) approved by the FDA?

Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) received FDA 510(k) clearance on 2026-04-08, under approval number K260197.

What company makes Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)?

Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) is manufactured by Suzhou Shenyun Medical Equipment Co., Ltd..

What is the FDA product code for Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)?

The FDA product code for Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) is GCJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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