510(k) · Cleared
ClearedSpinewand Surgical Device
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 13, 2010 as substantially equivalent to K053447 (Arthrocare Corp., 2005) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 2001. 3 later devices descend from it.
- Decided
- May 13, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K010811 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK010811 Perc-D SpinewandArthrocare Corp. · 2001
- 3 generations backK020621 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 2 generations backK030954 Arthrocare Percd SpinewandArthrocare Corp. · 2003
- 1 generation backK053447 Arthrocare Perc-D SpinewandArthrocare Corp. · 2005
- This deviceK100353 Spinewand Surgical DeviceArthrocare Corp. · 2010
- Descendant · cites it directly · 1 of its ownK132099 Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG…ArthroCare Corporation · 2013
- Descendant · cites it directly · 0 of its ownK162490 Disc-FX SystemElliquence, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK150915 Spinaut-PImedicom Co., Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010811 | Perc-D Spinewand | Arthrocare Corp. | 2001 | — |
| −3 | K020621 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −2 | K030954 | Arthrocare Percd Spinewand | Arthrocare Corp. | 2003 | — |
| −1 | K053447 | Arthrocare Perc-D Spinewand | Arthrocare Corp. | 2005 | — |
| 0 (this device) | K100353 | Spinewand Surgical Device | Arthrocare Corp. | 2010 | — |
| +1 | K132099 | Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG Spinewand | ArthroCare Corporation | 2013 | — |
| +1 | K162490 | Disc-FX System | Elliquence, LLC | 2017 | — |
| +2 | K150915 | Spinaut-P | Imedicom Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (4)
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 |
|---|---|---|---|
| * | K053447 | Arthrocare Perc-D SpinewandSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare Perc-D SpineWand K053447 (December 27, 2005) ArthroCare Perc-D SpineWand K030954 (April 16, 2003) ArthroCare Perc-D SpineWand… | 2005 |
| * | K030954 | Arthrocare Percd SpinewandSummary page 1…878.4400) Predicate Devices ArthroCare Perc-D SpineWand K053447 (December 27, 2005) ArthroCare Perc-D SpineWand K030954 (April 16, 2003) ArthroCare Perc-D SpineWand K020621 (March 28, 2002) ArthroCare Perc-D SpineWand… | 2003 |
| * | K020621 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsSummary page 1…K053447 (December 27, 2005) ArthroCare Perc-D SpineWand K030954 (April 16, 2003) ArthroCare Perc-D SpineWand K020621 (March 28, 2002) ArthroCare Perc-D SpineWand K0 1081 1 (May 30, 200 1) Product Description The Wands are bip… | 2002 |
| * | K010811 | Perc-D SpinewandSummary page 1…and K030954 (April 16, 2003) ArthroCare Perc-D SpineWand K020621 (March 28, 2002) ArthroCare Perc-D SpineWand K0 1081 1 (May 30, 200 1) Product Description The Wands are bipolar, single use, high frequency electrosurgical devices. The Coblator IQ… | 2001 |
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 9 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K132099 (ArthroCare Corporation, 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K053447.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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® Coblator IQTM Perc-D® 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/K100353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100353: Spinewand Surgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100353
Report an extraction error
Are you the manufacturer?
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