Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)— 510(k) K260197
Substantially EquivalentSuzhou Shenyun Medical Equipment Co., Ltd.
FDA 510(k) clearance K260197 for Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B), Substantially Equivalent on 2026-04-08. Applicant: Suzhou Shenyun Medical Equipment Co., Ltd.. Device class: 2.
Summary
The Shogun Axis Fascial Closure System covers six models (1018S through 1518B). It's filed under GCJ, laparoscopes for general and plastic surgery. The record doesn't describe the device beyond its name.
Class II, 21 CFR 876.1500, filed as a Traditional 510(k). The record lists Gastroenterology and Urology as the advisory panel and General and Plastic Surgery as the review panel.
Suzhou Shenyun Medical Equipment filed from Suzhou, China. Review took 76 days (January 22 to April 8, 2026).
Clearance details
- Applicant
- Suzhou Shenyun Medical Equipment Co., Ltd.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code GCJ
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.