510(k) · Cleared
ClearedGenicon Disposable Electrosurgical Instrumentation, Model 533-005-910
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genicon · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 10, 2006 as substantially equivalent to K984240 (Ethicon Endo-Surgery, Inc., 1999) after a 141-day review. Its family tree reaches back 2 generations to 1991. 6 later devices descend from it.
- Decided
- Oct 10, 2006
- Review
- 141 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910831 (1991). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- 1 generation backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
- This deviceK061417 Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910Genicon · 2006
- Descendant · cites it directly · 2 of its ownK132771 Kingston Endoscopic Surgical InstrumentsQingdao Kingston Medical Devices, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK171825 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic…Hunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK171752 X-SurgeGenicon, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK211019 Disposable Monopolar Laparoscopic Tips and Reusable HandlesDannik, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK210569 Disposable Monopolar Laparoscopic Shafts and Reusable HandlesDannik, LLC · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132771Kingston Endoscopic Surgical InstrumentsQingdao Kingston Medical Devices, Ltd. · 2014 · cites it directly2descendants
- K171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018 · 2 generations on1descendant
- K171752X-SurgeGenicon, Inc. · 2017 · cites it directly1descendant
- K211019Disposable Monopolar Laparoscopic Tips and Reusable HandlesDannik, LLC · 2021 · 3 generations on0descendants
- K210569Disposable Monopolar Laparoscopic Shafts and Reusable HandlesDannik, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| −1 | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | 1 |
| 0 (this device) | K061417 | Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 | Genicon | 2006 | — |
| +1 | K132771 | Kingston Endoscopic Surgical Instruments | Qingdao Kingston Medical Devices, Ltd. | 2014 | — |
| +2 | K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical… | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2018 | — |
| +1 | K171752 | X-Surge | Genicon, Inc. | 2017 | — |
| +3 | K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles | Dannik, LLC | 2021 | — |
| +2 | K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable Handles | Dannik, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 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 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 |
|---|---|---|---|
| * | K984240 | Endopath Endoscopic InstrumentsSummary page 1…ce and Accessories (21 CFR 878.4400, Product Code GEl) Legally Marketed Device - Ethicon ENDOPATH (K984240) Device Description - The GENICON disposable electrosurgical instruments are singl… | 1999 |
What descends from it? (6)
3 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 15 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K132771 (Qingdao Kingston Medical Devices, Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K984240.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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 as stated in the FDA summary.
https://510kreport.com/device/K061417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061417: Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061417
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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