510(k) · Cleared
ClearedArthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare Electrosurgery Wand, Models H2000
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 Sep 24, 1999 as substantially equivalent to K971532 (Arthrocare Corp., 1997) after a 21-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 24, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K943450 (1995). 12 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 4 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 2 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 1 generation backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- This deviceK992972 Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch…Arthrocare Corp. · 1999
- Descendant · cites it directly · 1 of its ownK012631 Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
- Descendant · cites it directly · 0 of its ownK062539 Ncontact Coagulation System KitNcontact Surgical, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
Most influential descendants
Showing 3 of 3 · See all- K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001 · cites it directly1descendant
- K062539Ncontact Coagulation System KitNcontact Surgical, Inc. · 2006 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −5 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −4 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −2 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −1 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| 0 (this device) | K992972 | Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord… | Arthrocare Corp. | 1999 | — |
| +1 | K012631 | Reprocessed Soft Tissue Ablators | Alliance Medical Corp. | 2001 | — |
| +1 | K062539 | Ncontact Coagulation System Kit | Ncontact Surgical, Inc. | 2006 | — |
| +2 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K971532 | Arthrocare Electrosurgery SystemSummary page 1…78.4400) Trade Name: ArthroCare® Electrosurgery System Generic/Common Name: Electrosurgical Device and Accessories Predicate Devices ArthroCare Electrosurgery System K971532; cleared on July 23, 1997 Intended Use The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation… | 1997 |
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K012631 (Alliance Medical Corp., 2001) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K971532.
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 ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during surgical procedures.
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/K992972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992972: Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare Electrosurgery Wand, Models H2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992972
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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