FDA 510(k)

쇼건 오시스™ 패스ialis 클로저 시스템 (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)

K-번호: K260197 · 2026-04-08

신청자Suzhou Shenyun Medical Equipment Co., Ltd.

결정일2026-04-08

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

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

자주 묻는 질문

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. The listed applicant is Suzhou Shenyun Medical Equipment Co., Ltd.. The 510(k) number is K260197.

When did Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) receive FDA 510(k) clearance?

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

Who is the listed applicant for Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)?

The FDA 510(k) record lists Suzhou Shenyun Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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쇼건 오시스™ 패스ialis 클로저 시스템 (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GCJ)

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