510(k) · Cleared
ClearedArthrocare Wands
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 Apr 10, 2006 as substantially equivalent to K053297 (Arthrocare Corp., 2005) after a 14-day review. Its family tree reaches back 2 generations to 2000. 16 later devices descend from it.
- Decided
- Apr 10, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001588 (2000). 16 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001588 Arthrocare System 2000 Controller, Arthrocare System 2000 Cable…Arthrocare Corp. · 2000
- 1 generation backK053297 Arthrocare 8000S Coblator Surgery SystemArthrocare Corp. · 2005
- This deviceK060823 Arthrocare WandsArthrocare Corp. · 2006
- Descendant · cites it directly · 12 of its ownK063172 Arthrocare Cavity SpinewandArthrocare Corp. · 2007 · Recalled
- Descendant · 2 generations on · 11 of its ownK091310 Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model…Dfine, Inc. · 2010
- Descendant · 3 generations on · 9 of its ownK142480 OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- Descendant · 4 generations on · 8 of its ownK152057 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- Descendant · 5 generations on · 7 of its ownK161949 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K063172Arthrocare Cavity SpinewandArthrocare Corp. · 2007 · cites it directly12descendants
- K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc. · 2010 · 2 generations on11descendants
- K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015 · 3 generations on9descendants
- K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015 · 4 generations on8descendants
- K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare… | Arthrocare Corp. | 2000 | — |
| −1 | K053297 | Arthrocare 8000S Coblator Surgery System | Arthrocare Corp. | 2005 | — |
| 0 (this device) | K060823 | Arthrocare Wands | Arthrocare Corp. | 2006 | — |
| +1 | K063172 | Arthrocare Cavity Spinewand | Arthrocare Corp. | 2007 | 1 |
| +2 | K091310 | Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 | Dfine, Inc. | 2010 | — |
| +3 | K142480 | OsteoCool V-2 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| +4 | K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| +5 | K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K053297 | Arthrocare 8000S Coblator Surgery SystemSummary page 1…878.4400) Predicate Device ArthroCare 8000S Coblator Surgery Systems K053297 Product Description The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices de… | 2005 |
What descends from it? (16)
See all 163 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 6 years and passes through 1 company; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K063172 (Arthrocare Corp., 2007) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K053297.
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 Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060823: Arthrocare Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060823
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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