510(k) · Cleared
ClearedArthrocare Electrosurgery 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 Oct 25, 2001 as substantially equivalent to K001302 (Arthrocare Corp., 2000) and 2 other predicates after an 80-day review. Its family tree reaches back 5 generations to 1994. 3 later devices descend from it.
- Decided
- Oct 25, 2001
- Review
- 80 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K936109 (1994). 25 ancestors in all, the oldest K853620 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 4 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 3 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 2 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 1 generation backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- This deviceK012519 Arthrocare Electrosurgery WandsArthrocare Corp. · 2001
- Descendant · cites it directly · 2 of its ownK014222 Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp. · 2002
- Descendant · 2 generations on · 1 of its ownK020622 Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot…Arthrocare Corp. · 2002
- Descendant · 3 generations on · 0 of its ownK022475 Modification to Arthrocare Controller (System 2000 and 8000)…Arthrocare Corp. · 2002
Most influential descendants
Showing 3 of 3 · See all- K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp. · 2002 · cites it directly2descendants
- K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp. · 2002 · 2 generations on1descendant
- K022475Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable…Arthrocare Corp. · 2002 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −4 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −3 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −2 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −1 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| 0 (this device) | K012519 | Arthrocare Electrosurgery Wands | Arthrocare Corp. | 2001 | — |
| +1 | K014222 | Arthrocare Controller, Patient Cable, Foot Control, Power Cord | Arthrocare Corp. | 2002 | — |
| +2 | K020622 | Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control… | Arthrocare Corp. | 2002 | — |
| +3 | K022475 | Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare… | Arthrocare Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K001302 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000…Summary page 1…ugust 3, 2001 Electrosurgical Cutting and Coagulation Device and Accessorics (21 CFR 878.4400) ArthroCare® Electrosurgery Wand Electrusurgical Device and Accessorics K001302 K981361 K990947 In Use The Elcctrosurgery Wands arc indicated for resection, ablation, and coagulation of soft… | 2000 |
| * | K981361 | Powerstar Bipolar ScissorsSummary page 1…2001 Electrosurgical Cutting and Coagulation Device and Accessorics (21 CFR 878.4400) ArthroCare® Electrosurgery Wand Electrusurgical Device and Accessorics K001302 K981361 K990947 In Use The Elcctrosurgery Wands arc indicated for resection, ablation, and coagulation of soft tissue a… | 1998 |
| * | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Summary page 1…ectrosurgical Cutting and Coagulation Device and Accessorics (21 CFR 878.4400) ArthroCare® Electrosurgery Wand Electrusurgical Device and Accessorics K001302 K981361 K990947 In Use The Elcctrosurgery Wands arc indicated for resection, ablation, and coagulation of soft tissue and hemost… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014222 | Arthrocare Controller, Patient Cable, Foot Control, Power Cord | 2002 | 2 |
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 7 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K014222 (Arthrocare Corp., 2002) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K001302.
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 ArthroCare Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following:
General Surgery
• cholecystectomy
• lysis of adhesions
• upper GI
• GI (other)
• splenectomy
• thyroidectomy
• hemiorrhaphy
• breast biopsy
• bowel resection
• pelvic adhesiolysis
• removal of lesions
• removal of polyps
• tumor biopsy
Gynecological Surgery
• lysis of adhesions
• hysterectomy
• salpingo-oophorectomy
• burch colposuspension
• myomectomy
• endometriosis
• ovariohysterectomy
• removal of tumors
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/K012519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012519: Arthrocare Electrosurgery Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012519
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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