510(k) · Cleared
ClearedUnimicro Suction Irriation Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimicro Medical Systems (Shenzhen) Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 4, 2014 as substantially equivalent to K103509 (Unimax Medical Systems, Inc., 2011) after a 52-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 4, 2014
- Review
- 52 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963646 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK963646 Stryker Strykeflow Suction Irrigator Gravity FlowStryker Endoscopy · 1997 · Recalled
- 2 generations backK041967 Genicon Suction Irrigation SystemGenicon · 2004
- 1 generation backK103509 Unimax Suction Irrigation SetUnimax Medical Systems, Inc. · 2011
- This deviceK141592 Unimicro Suction Irriation Tubing SetUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK242927 Suction Irrigation Tubing SetAdvamedix, GmbH · 2024
- Descendant · cites it directly · 0 of its ownK172794 Suction Irrigation SetWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963646 | Stryker Strykeflow Suction Irrigator Gravity Flow | Stryker Endoscopy | 1997 | 2 |
| −2 | K041967 | Genicon Suction Irrigation System | Genicon | 2004 | — |
| −1 | K103509 | Unimax Suction Irrigation Set | Unimax Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K141592 | Unimicro Suction Irriation Tubing Set | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2014 | — |
| +1 | K242927 | Suction Irrigation Tubing Set | Advamedix, GmbH | 2024 | — |
| +1 | K172794 | Suction Irrigation Set | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K103509 | Unimax Suction Irrigation SetSummary page 6…Name and Code regulation number Unimax Suction Unimax ClassⅡ, 21CFR K103509 Suction Irrigation Medical GCJ 876.1500 Irrigation Set Systems Inc. 5. Intende… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K242927 (Advamedix, GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K103509.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Unimicro Suction Irrigation Tubing set is available with an array of probe designs to facilitate lavage during laparoscopic surgery.
This device has applications in laparoscopic gynecologic, general, thoracic and urology 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/K141592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141592: Unimicro Suction Irriation Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141592
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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