510(k) · Cleared
ClearedArthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG Spinewand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 22, 2013 as substantially equivalent to K100353 (Arthrocare Corp., 2010) after a 45-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Aug 22, 2013
- Review
- 45 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010811 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK010811 Perc-D SpinewandArthrocare Corp. · 2001
- 4 generations backK020621 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 3 generations backK030954 Arthrocare Percd SpinewandArthrocare Corp. · 2003
- 2 generations backK053447 Arthrocare Perc-D SpinewandArthrocare Corp. · 2005
- 1 generation backK100353 Spinewand Surgical DeviceArthrocare Corp. · 2010
- This deviceK132099 Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG…ArthroCare Corporation · 2013
- Descendant · cites it directly · 0 of its ownK150915 Spinaut-PImedicom Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K150915Spinaut-PImedicom Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010811 | Perc-D Spinewand | Arthrocare Corp. | 2001 | — |
| −4 | K020621 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −3 | K030954 | Arthrocare Percd Spinewand | Arthrocare Corp. | 2003 | — |
| −2 | K053447 | Arthrocare Perc-D Spinewand | Arthrocare Corp. | 2005 | — |
| −1 | K100353 | Spinewand Surgical Device | Arthrocare Corp. | 2010 | — |
| 0 (this device) | K132099 | Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG Spinewand | ArthroCare Corporation | 2013 | — |
| +1 | K150915 | Spinaut-P | Imedicom Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K100353 | Spinewand Surgical DeviceSummary page 2…ation for. use statement of the predicate device and there have been no other device, design or material changes since the previous clearance of these predicate devices (K100353), new'testing was deemed to be unnecessary. The performance testing previously conducted as part of the design control activities… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150915 | Spinaut-P | 2016 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K150915 (Imedicom Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100353.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 IQ Perc-D Spine Wands (Coblator IQ DLR and Coblator IQ DLG SpineWands) are indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated lumbar and lumbosacral discs. The Wands are designed to be used exclusively with the ArthroCare Coblator IQ Controller.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132099: Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG Spinewand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132099
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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