510(k) · Cleared
ClearedSystem 7500-B Electrosurgical Unit; Abcflex Probe for Flexible Endoscopy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Electrosurgery · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 3, 2005 as substantially equivalent to K981220 (Aspen Laboratories, Inc., 1998) and 1 other predicate after a 9-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Feb 3, 2005
- Review
- 9 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981220 (1998). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK981220 System 7500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1998
- This deviceK050161 System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible…Conmed Electrosurgery · 2005
- Descendant · cites it directly · 3 of its ownK152860 Helixar Electrosurgical Generator with Argon Beam Coagulation…Conmed Corporation · 2015
- Descendant · 2 generations on · 2 of its ownK172671 HelixAR Electrosurgical Generator with Argon Beam Coagulation…Conmed Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK213354 Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify…Conmed Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK203522 Surn5 Electrosurgical Argon Beam Generator and AccessoriesSurnic Corporation · 2021
Most influential descendants
Showing 4 of 4 · See all- K152860Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile PedestalConmed Corporation · 2015 · cites it directly3descendants
- K172671HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile PedestalConmed Corporation · 2017 · 2 generations on2descendants
- K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation · 2022 · 3 generations on0descendants
- K203522Surn5 Electrosurgical Argon Beam Generator and AccessoriesSurnic Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981220 | System 7500 Abc Electrosurgical Unit | Aspen Laboratories, Inc. | 1998 | — |
| 0 (this device) | 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 | — |
| +2 | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile… | Conmed Corporation | 2017 | — |
| +3 | K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar… | Conmed Corporation | 2022 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K981220 | System 7500 Abc Electrosurgical UnitSummary page 1…oagulation Device and accessories (21 CFR 878.4400) 79 GEl Predicate Device: System 7500® Electrosurgical Unit, K981220, cleared 27-April-1998 ABC® Probe for Flexible Endoscopes, K990586, cleared 17-May-1 999 Device Descri… | 1998 |
| * | K990586 | Conmed Abc Probe for Flexible EndoscopesSummary page 1…79 GEl Predicate Device: System 7500® Electrosurgical Unit, K981220, cleared 27-April-1998 ABC® Probe for Flexible Endoscopes, K990586, cleared 17-May-1 999 Device Description: The System 7500®-B is an electrosurgical generator with Argon Beam Coagulation (ABC )… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152860 | Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile Pedestal | 2015 | 3 |
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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 System 7500® -B is used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit. The ABCFIeX TM Probe is intended for use with the System 7500® -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050161: System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible Endoscopy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050161
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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