510(k) · Cleared
ClearedLAGIS Suction Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lagis Enterprise Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 17, 2025 as substantially equivalent to K150253 (Taiwan Surgical Corporation, 2015) after a 90-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Mar 17, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K963646 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK963646 Stryker Strykeflow Suction Irrigator Gravity FlowStryker Endoscopy · 1997 · Recalled
- 3 generations backK041967 Genicon Suction Irrigation SystemGenicon · 2004
- 2 generations backK103509 Unimax Suction Irrigation SetUnimax Medical Systems, Inc. · 2011
- 1 generation backK150253 Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation…Taiwan Surgical Corporation · 2015
- This deviceK243867 LAGIS Suction Irrigation SystemLagis Enterprise Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963646 | Stryker Strykeflow Suction Irrigator Gravity Flow | Stryker Endoscopy | 1997 | 2 |
| −3 | K041967 | Genicon Suction Irrigation System | Genicon | 2004 | — |
| −2 | K103509 | Unimax Suction Irrigation Set | Unimax Medical Systems, Inc. | 2011 | — |
| −1 | K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm | Taiwan Surgical Corporation | 2015 | — |
| 0 (this device) | K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | 2025 | — |
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? (1)
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 |
|---|---|---|---|
| * | K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mmSummary page 6…oscope, General & Plastic Surgery Name: (21 CFR 876.1500, Product Code GCJ) Regulatory Class: Class II Predicate Device: 510(k) Number - K150253 Product Code – GCJ Submitter - TAIWAN SURGICAL CORPORATION… | 2015 |
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 28 years and passes through 5 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 4 ancestors has 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. 2025, 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 LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243867: LAGIS Suction Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243867
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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