510(k) · Cleared
ClearedShogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Shenyun Medical Equipment Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 8, 2026 as substantially equivalent to K163654 (Covidien, LLC, 2017) and 1 other predicate after a 76-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Apr 8, 2026
- Review
- 76 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011257 (2001). 9 ancestors in all, the oldest K980123 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK011257 Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc. · 2001
- 4 generations backK112349 Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 3 generations backK130435 Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- 2 generations backK151548 VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015
- 1 generation backK163654 VersaOne fascial closure system bladed trocar, VersaOne fascial…Covidien, LLC · 2017
- This deviceK260197 Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B…Suzhou Shenyun Medical Equipment Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM) | Ethicon Endo-Surgery, Inc. | 2001 | — |
| −4 | K112349 | Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 6 |
| −3 | K130435 | Versaport V2 Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| −2 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | Covidien | 2015 | — |
| −1 | K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system… | Covidien, LLC | 2017 | — |
| 0 (this device) | K260197 | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless…Summary page 5…876.1500 Product Code(s) GCJ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K163654 VersaOne Fascial Closure System Bladed Trocar, VersaOne GCJ Fascial Closure System Bladeless Trocar, VersaOne Fascial Closure Sy… | 2017 |
| * | K980123 | Carter-Thomason Needle-Point Suture Passer Instrument SetSummary page 5…roduct Code K163654 VersaOne Fascial Closure System Bladed Trocar, VersaOne GCJ Fascial Closure System Bladeless Trocar, VersaOne Fascial Closure System Optical Trocar K980123 Carter-Thomason Il Port Closure System (legacy clearance GCJ holder : CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET)… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260197: Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260197
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026