510(k) · Cleared
ClearedArthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Plasma Scalpel GS, C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 30, 2000 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 30, 2000
- Review
- 36 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK001302 Arthrocare System 2000 Controller, Arthrocare System 2000 Cable…Arthrocare Corp. · 2000
- Descendant · cites it directly · 3 of its ownK012519 Arthrocare Electrosurgery WandsArthrocare Corp. · 2001
- Descendant · 2 generations on · 2 of its ownK014222 Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp. · 2002
- Descendant · 3 generations on · 1 of its ownK020622 Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot…Arthrocare Corp. · 2002
- Descendant · cites it directly · 1 of its ownK012631 Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
- Descendant · 2 generations on · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K012519Arthrocare Electrosurgery WandsArthrocare Corp. · 2001 · cites it directly3descendants
- K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp. · 2002 · 2 generations on2descendants
- K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp. · 2002 · 3 generations on1descendant
- K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001 · cites it directly1descendant
- K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001302 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare… | Arthrocare Corp. | 2000 | — |
| +1 | K012519 | Arthrocare Electrosurgery Wands | Arthrocare Corp. | 2001 | — |
| +2 | K014222 | Arthrocare Controller, Patient Cable, Foot Control, Power Cord | Arthrocare Corp. | 2002 | — |
| +3 | K020622 | Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control… | Arthrocare Corp. | 2002 | — |
| +1 | K012631 | Reprocessed Soft Tissue Ablators | Alliance Medical Corp. | 2001 | — |
| +2 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 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?
- Of its descendants, K012519 (Arthrocare Corp., 2001) has gone furthest, with 3 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.
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 | — |
https://510kreport.com/device/K001302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001302: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Plasma Scalpel GS, C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001302
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026