510(k) · Cleared
ClearedDisposable Monopolar Laparoscopic Shafts and Reusable Handles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dannik, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 16, 2021 as substantially equivalent to K171752 (Genicon, Inc., 2017) after a 171-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Aug 16, 2021
- Review
- 171 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910831 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- 3 generations backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
- 2 generations backK061417 Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910Genicon · 2006
- 1 generation backK171752 X-SurgeGenicon, Inc. · 2017
- This deviceK210569 Disposable Monopolar Laparoscopic Shafts and Reusable HandlesDannik, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| −3 | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | 1 |
| −2 | K061417 | Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 | Genicon | 2006 | — |
| −1 | K171752 | X-Surge | Genicon, Inc. | 2017 | — |
| 0 (this device) | K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable Handles | Dannik, LLC | 2021 | — |
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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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 |
|---|---|---|---|
| * | K171752 | X-SurgeSummary page 4…VICE The Disposable Monopolar Laparoscopic Shafts and Reusable Handles claim Substantial Equivalence to GENICON X-Surge laparoscopic instruments cleared under 510(k) K171752. 4. DEVICE DESCRIPTION The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are sterile packaged single use mon… | 2017 |
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 30 years and passes through 5 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
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/K210569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210569: Disposable Monopolar Laparoscopic Shafts and Reusable Handles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210569
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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