510(k) · Cleared
ClearedHelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 4, 2017 as substantially equivalent to K152860 (Conmed Corporation, 2015) after a 29-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Oct 4, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981220 (1998). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK981220 System 7500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1998
- 2 generations backK050161 System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible…Conmed Electrosurgery · 2005
- 1 generation backK152860 Helixar Electrosurgical Generator with Argon Beam Coagulation…Conmed Corporation · 2015
- This deviceK172671 HelixAR Electrosurgical Generator with Argon Beam Coagulation…Conmed Corporation · 2017
- Descendant · cites it directly · 0 of its ownK213354 Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify…Conmed Corporation · 2022
- Descendant · cites it directly · 0 of its ownK203522 Surn5 Electrosurgical Argon Beam Generator and AccessoriesSurnic Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981220 | System 7500 Abc Electrosurgical Unit | Aspen Laboratories, Inc. | 1998 | — |
| −2 | K050161 | System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible Endoscopy | Conmed Electrosurgery | 2005 | — |
| −1 | K152860 | Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile… | Conmed Corporation | 2015 | — |
| 0 (this device) | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile… | Conmed Corporation | 2017 | — |
| +1 | K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar… | Conmed Corporation | 2022 | — |
| +1 | K203522 | Surn5 Electrosurgical Argon Beam Generator and Accessories | Surnic Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K152860 | Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile PedestalSummary page 4…D. Predicate Device Primary Device Name: HelixAR ABC System Company Name: CONMED Corporation 510(k): K152860 This predicate has not been subject to a design-related recall. E. Device Description The HelixAR ABC System is… | 2015 |
What descends from it? (2)
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K213354 (Conmed Corporation, 2022) 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. 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?
The CONMED HelixAR ABC System is intended to deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of 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/K172671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172671: HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172671
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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