510(k) · Cleared
ClearedArthrocare Perc-D Spinewand
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 Dec 27, 2005 as substantially equivalent to K030954 (Arthrocare Corp., 2003) after an 18-day review. Its family tree reaches back 3 generations to 2001. 6 later devices descend from it.
- Decided
- Dec 27, 2005
- Review
- 18 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010811 (2001). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK010811 Perc-D SpinewandArthrocare Corp. · 2001
- 2 generations backK020621 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 1 generation backK030954 Arthrocare Percd SpinewandArthrocare Corp. · 2003
- This deviceK053447 Arthrocare Perc-D SpinewandArthrocare Corp. · 2005
- Descendant · cites it directly · 3 of its ownK100353 Spinewand Surgical DeviceArthrocare Corp. · 2010
- Descendant · cites it directly · 2 of its ownK061259 Modification to Arthrocare Perc-D SpinewandArthrocare Corp. · 2006
- Descendant · cites it directly · 1 of its ownK132797 L'DISQU&I Corporation · 2014
- Descendant · 2 generations on · 1 of its ownK132099 Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG…ArthroCare Corporation · 2013
- Descendant · 2 generations on · 0 of its ownK162490 Disc-FX SystemElliquence, LLC · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100353Spinewand Surgical DeviceArthrocare Corp. · 2010 · cites it directly3descendants
- K061259Modification to Arthrocare Perc-D SpinewandArthrocare Corp. · 2006 · cites it directly2descendants
- K132797L'DISQU&I Corporation · 2014 · cites it directly1descendant
- K132099Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG SpinewandArthroCare Corporation · 2013 · 2 generations on1descendant
- K162490Disc-FX SystemElliquence, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010811 | Perc-D Spinewand | Arthrocare Corp. | 2001 | — |
| −2 | K020621 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −1 | K030954 | Arthrocare Percd Spinewand | Arthrocare Corp. | 2003 | — |
| 0 (this device) | K053447 | Arthrocare Perc-D Spinewand | Arthrocare Corp. | 2005 | — |
| +1 | K100353 | Spinewand Surgical Device | Arthrocare Corp. | 2010 | — |
| +1 | K061259 | Modification to Arthrocare Perc-D Spinewand | Arthrocare Corp. | 2006 | — |
| +1 | K132797 | L'DISQ | U&I Corporation | 2014 | — |
| +2 | K132099 | Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG Spinewand | ArthroCare Corporation | 2013 | — |
| +2 | K162490 | Disc-FX System | Elliquence, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K030954 | Arthrocare Percd SpinewandSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare PercD SpineWand K030954 Product Description The Wands arc bipolar, single use, high frequency clectrosurgical devices. Intended Use The Perc-D… | 2003 |
What descends from it? (6)
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100353 (Arthrocare Corp., 2010) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K030954.
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 Perc-D' m SpineWand is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053447: Arthrocare Perc-D Spinewand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053447
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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