510(k) · Cleared
ClearedSurn5 Electrosurgical Argon Beam Generator and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surnic Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 22, 2021 as substantially equivalent to K172671 (Conmed Corporation, 2017) after an 83-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Feb 22, 2021
- Review
- 83 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981220 (1998). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK981220 System 7500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1998
- 3 generations backK050161 System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible…Conmed Electrosurgery · 2005
- 2 generations backK152860 Helixar Electrosurgical Generator with Argon Beam Coagulation…Conmed Corporation · 2015
- 1 generation backK172671 HelixAR Electrosurgical Generator with Argon Beam Coagulation…Conmed Corporation · 2017
- This deviceK203522 Surn5 Electrosurgical Argon Beam Generator and AccessoriesSurnic Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981220 | System 7500 Abc Electrosurgical Unit | Aspen Laboratories, Inc. | 1998 | — |
| −3 | K050161 | System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible Endoscopy | Conmed Electrosurgery | 2005 | — |
| −2 | K152860 | Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile… | Conmed Corporation | 2015 | — |
| −1 | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile… | Conmed Corporation | 2017 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile PedestalSummary page 4…Code: GEI 21CFR Regulation Number: 878.4400 3. Predicate Device Product HelixAR ABC Systems 510(K) K172671 4. Device Description Surn5 electrosurgical argon beam Generator and accessories have Monopolar Pure cut, Monopolar Bland Cut… | 2017 |
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 23 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K172671.
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 Surn5 Electrosurgical Argon Beam Generator and Accessories are indicated for monopolar or bipolar surgery to achieve argon beam and cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
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/K203522 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203522: Surn5 Electrosurgical Argon Beam Generator and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203522
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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