# K260197: Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Shenyun Medical Equipment Co., Ltd.
- Decided: Apr 8, 2026 after 76 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011257 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163654: VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar, Covidien, LLC (2017) Summary page 5.
- K980123: Carter-Thomason Needle-Point Suture Passer Instrument Set, Louisville Laboratories, Inc. (1998) Summary page 5.

## Indications for use
The Shogun Axis™ Fascial Closure Systems (Optical & Bladeless) are intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.

Source page: https://510kreport.com/device/K260197
Methodology: https://510kreport.com/methodology