510(k) · Cleared
ClearedDisposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hunan Handlike Minimally Invasive Surgery Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 13, 2018 as substantially equivalent to K132771 (Qingdao Kingston Medical Devices, Ltd., 2014) and 1 other predicate after a 239-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Feb 13, 2018
- Review
- 239 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K910831 (1991). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK132771 Kingston Endoscopic Surgical InstrumentsQingdao Kingston Medical Devices, Ltd. · 2014
- This deviceK171825 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic…Hunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK211019 Disposable Monopolar Laparoscopic Tips and Reusable HandlesDannik, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K211019Disposable Monopolar Laparoscopic Tips and Reusable HandlesDannik, LLC · 2021 · cites it directly0descendants
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 | K132771 | Kingston Endoscopic Surgical Instruments | Qingdao Kingston Medical Devices, Ltd. | 2014 | — |
| 0 (this device) | K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical… | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K132771 | Kingston Endoscopic Surgical InstrumentsSummary page 5…Regulation number 878.4400 Regulation class II Regulation name Electrosurgical, Cutting & Coagulation & Accessories 510(k) Number K132771 Product Code GEI Manufacturer Qingdao Kingston Medical Devices Ltd. Trade Name Endosco… | 2014 |
| * | K102921 | Endoscopic Monopolar Instruments and AccessoriesSummary page 5…Regulation number 878.4400 Regulation class II Regulation name Electrosurgical, Cutting & Coagulation & Accessories 510(k) Number K102921 Product Code GEI Manufacturer BEMA GmbH & Co. KG 5. Device Description Endoscopic Surgical Instrument… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles | 2021 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K211019 (Dannik, LLC, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171825: Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171825
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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