K260197
- 510(k) number
- K260197
- Device name
- Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
- Applicant
- Suzhou Shenyun Medical Equipment Co., Ltd. CN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-04-08
- Date received
- 2026-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260197.pdf
Official FDA record: K260197
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.