510(k) · Cleared
ClearedDisposable Monopolar Laparoscopic Tips 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 Oct 28, 2021 as substantially equivalent to K171825 (Hunan Handlike Minimally Invasive Surgery Co., Ltd., 2018) after a 206-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Oct 28, 2021
- Review
- 206 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910831 (1991). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- 4 generations backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
- 3 generations backK061417 Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910Genicon · 2006
- 2 generations backK132771 Kingston Endoscopic Surgical InstrumentsQingdao Kingston Medical Devices, Ltd. · 2014
- 1 generation backK171825 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic…Hunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018
- This deviceK211019 Disposable Monopolar Laparoscopic Tips and Reusable HandlesDannik, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| −4 | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | 1 |
| −3 | K061417 | Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 | Genicon | 2006 | — |
| −2 | K132771 | Kingston Endoscopic Surgical Instruments | Qingdao Kingston Medical Devices, Ltd. | 2014 | — |
| −1 | K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical… | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2018 | — |
| 0 (this device) | K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles | Dannik, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2011 | 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 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 |
|---|---|---|---|
| * | K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentSummary page 4…copic Tips and Reusable Handles claim Substantial Equivalence to Hunan Handlike Minimally Invasive Surgery Co. Endoscopic Surgical Instruments cleared under 510(k) K171825. 4. DEVICE DESCRIPTION The Disposable Monopolar Laparoscopic Tips and Reusable Handles are sterile packaged single use mon… | 2018 |
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 6 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 11 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 Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.
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/K211019 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211019: Disposable Monopolar Laparoscopic Tips and Reusable Handles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211019
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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