510(k) · Cleared
ClearedArthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model H2000-04; Powercord, Model 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 Jun 19, 2001 as substantially equivalent to K000778 (Arthrocare Corp., 2000) and 4 other predicates after a 21-day review. Its family tree reaches back 1 generation to 2000. 41 later devices descend from it.
- Decided
- Jun 19, 2001
- Review
- 21 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K000778 (2000). 5 ancestors in all. 41 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000778 Entec Reflex Wand 55, Model E4055-01, E4045-01Arthrocare Corp. · 2000
- This deviceK011634 Arthrocare Controller, Model H2000; Arthrocare Cable, Model…Arthrocare Corp. · 2001
- Descendant · cites it directly · 40 of its ownK020832 Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord…Arthrocare Corp. · 2002
- Descendant · 2 generations on · 24 of its ownK040338 Arthrocare Controller, Cable, Foot Control, Power Cord, Wands…Arthrocare Corp. · 2004
- Descendant · 3 generations on · 21 of its ownK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- Descendant · 4 generations on · 20 of its ownK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- Descendant · 5 generations on · 19 of its ownK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K020832Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, WandsArthrocare Corp. · 2002 · cites it directly40descendants
- K040338Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02…Arthrocare Corp. · 2004 · 2 generations on24descendants
- K071963Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 3 generations on21descendants
- K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 4 generations on20descendants
- K082323Arthrocare ArthrowandsArthrocare Corp. · 2008 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01 | Arthrocare Corp. | 2000 | — |
| 0 (this device) | K011634 | Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02… | Arthrocare Corp. | 2001 | — |
| +1 | K020832 | Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands | Arthrocare Corp. | 2002 | — |
| +2 | K040338 | Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models… | Arthrocare Corp. | 2004 | — |
| +3 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +4 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +5 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01Summary page 1…re® Orthopedic Electrosurgery System ArthroCare® Electrosurgery System Visage® Cosmetic Surgery System ArthroCare® Bipolar Loop Electrosurgical Device and Accessories K000778 KO001588 K001936 K003624 K010568 03 Intended Uses « The ENTec ReFlex Wand is indicated for ablation and coagul… | 2000 |
| * | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000…Summary page 3…ce This Special 510(k) proposes a modification in materials to the Wand component of the Electrosurgery Systems, which were previously cleared in K000778 (May 3, 2000), K001588 (August 17, 2000), K001936 (July 19, 2000), K003624 (December 20, 2000), and K010568 (March 27, 2001). The technology, principle… | 2000 |
| * | K001936 | Arthrocare Controller, Arthrocare Cable, Footswitch, PowercordSummary page 1…ctrosurgery System ArthroCare® Electrosurgery System Visage® Cosmetic Surgery System ArthroCare® Bipolar Loop Electrosurgical Device and Accessories K000778 KO001588 K001936 K003624 K010568 03 Intended Uses « The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tiss… | 2000 |
| * | K003624 | Refinity System, Refinity Handpiece and Cable, Refinity Footswitch, Refinity Power Cord…Summary page 1…ery System ArthroCare® Electrosurgery System Visage® Cosmetic Surgery System ArthroCare® Bipolar Loop Electrosurgical Device and Accessories K000778 KO001588 K001936 K003624 K010568 03 Intended Uses « The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in ot… | 2000 |
| * | K010568 | Arthrocare Urology Electrosurgery SystemSummary page 1…em ArthroCare® Electrosurgery System Visage® Cosmetic Surgery System ArthroCare® Bipolar Loop Electrosurgical Device and Accessories K000778 KO001588 K001936 K003624 K010568 03 Intended Uses « The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in otolaryngo… | 2001 |
What descends from it? (41)
See all 412 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?
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 ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) procedures, including the treatment of snoring, nasal airway obstruction by reduction of hypertrophic nasal turbinates, and submucosal tissue shrinkage. The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures. The…
Read the full statement (246 words)
The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) procedures, including the treatment of snoring, nasal airway obstruction by reduction of hypertrophic nasal turbinates, and submucosal tissue shrinkage.
The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
The ENTec Surgery System is intended for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including head, neck, oral, and sinus surgery.
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
The ArthroCare Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general, plastic, and reconstructive surgery. It is intended to be used in procedures using conductive solutions, such as normal saline.
The Visage Cosmetic Surgery System is a bipolar electrosurgical device intended for general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.
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/K011634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011634: Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model H2000-04; Powercord, Model H2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011634
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026