510(k) · Cleared
ClearedLAP-iX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sejong Medical Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 21, 2017 as substantially equivalent to K934828 (Conmedcorp, 1994) after a 53-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Nov 21, 2017
- Review
- 53 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934828 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK934828 Conmed Universal PlusConmedcorp · 1994
- This deviceK173112 LAP-iXSejong Medical Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK200639 LAP-iXSejong Medical Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK253165 LAP-iX2NSejong Medical Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK230593 VictanJiangsu Haize Medical Scientific Development Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934828 | Conmed Universal Plus | Conmedcorp | 1994 | — |
| 0 (this device) | K173112 | LAP-iX | Sejong Medical Co., Ltd. | 2017 | — |
| +1 | K200639 | LAP-iX | Sejong Medical Co., Ltd. | 2021 | — |
| +2 | K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026 | — |
| +1 | K230593 | Victan | Jiangsu Haize Medical Scientific Development Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K934828 | Conmed Universal PlusSummary page 4… Classification: Class II Classification regulation: 21 CFR 878.4400 Product Code: GEI 4. Predicate Devices: CONMED UNIVERSAL PLUS (K934828) by CONMED CORP 5. Description: The LAP-iX provides suction or irrigation and conducts high-frequency monopolar… | 1994 |
What descends from it? (3)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K200639 (Sejong Medical Co., Ltd., 2021) has gone furthest, with 1 descendant 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. 2017, 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?
LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173112: LAP-iX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173112
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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