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..
Summary
The Shogun Axis Fascial Closure System covers six SKU variants for closing laparoscopic port-site fasciae. Product code GCJ covers laparoscopic instruments broadly; fascial closure devices help prevent post-laparoscopy incisional hernias at port sites.
Gastroenterology, Urology panel, Traditional 510(k). Fascial closure is a small but active corner of GCJ with established predicates from Covidien (Part of Medtronic), Ethicon, and several Chinese manufacturers.
Suzhou Shenyun Medical Equipment Co. files from Suzhou, China. Two-and-a-half-month review clock, short for a multi-SKU filing, indicating a focused predicate comparison.
Clearance details
- Applicant
- Suzhou Shenyun Medical Equipment Co., Ltd.
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Adverse 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.