510(k) · Cleared
ClearedDannik Laparoscopic Suction Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dannik · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 19, 2019 as substantially equivalent to K103509 (Unimax Medical Systems, Inc., 2011) after a 56-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Nov 19, 2019
- Review
- 56 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, 1 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 deviceK192643 Dannik Laparoscopic Suction Irrigation SystemDannik · 2019
- Descendant · cites it directly · 1 of its ownK222575 HurriChem Device KitThermasolutions, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK231622 REGER Nebulizer Irrigation CannulaReger Medizintechnik, GmbH · 2023
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) | K192643 | Dannik Laparoscopic Suction Irrigation System | Dannik | 2019 | — |
| +1 | K222575 | HurriChem Device Kit | Thermasolutions, LLC | 2022 | — |
| +2 | K231622 | REGER Nebulizer Irrigation Cannula | Reger Medizintechnik, GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 4…6.1500, Product Code GCJ) 3. Substantially Equivalent Device • Legally Marketed (unmodified Devices): The Unimax Suction Irrigation Set FDA 510K (K103509) 4. Device Description The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a lapa… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222575 | HurriChem Device Kit | 2022 | 1 |
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 22 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K222575 (Thermasolutions, LLC, 2022) has gone furthest, with 1 descendant 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. 2019, 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 DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate
blood, and tissue debris from the surgical site
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192643: Dannik Laparoscopic 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/K192643
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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