510(k) · Cleared
ClearedArthrocare Electrosurgery System
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 Jul 23, 1997 as substantially equivalent to K943450 (Arthrocare Corp., 1995) and 7 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1995. 1,029 later devices descend from it.
- Decided
- Jul 23, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to K943450 (1995). 11 ancestors in all, the oldest K800617 (1980). 1,029 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 3 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 2 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 1 generation backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- This deviceK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- Descendant · cites it directly · 977 of its ownK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- Descendant · 2 generations on · 973 of its ownK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- Descendant · 2 generations on · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- Descendant · 3 generations on · 705 of its ownK022266 Aurora SRSyneron Medical, Ltd. · 2002
- Descendant · 3 generations on · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
Showing 5 of 1,029 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,029 · See all- K974521Vnus Closure SystemVnus Medical Technologies, Inc. · 1998 · cites it directly977descendants
- K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 1999 · 2 generations on973descendants
- K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · 2 generations on714descendants
- K022266Aurora SRSyneron Medical, Ltd. · 2002 · 3 generations on705descendants
- K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · 3 generations on695descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −3 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −2 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −1 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| 0 (this device) | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| +1 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| +2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| +2 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| +3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| +3 | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… | Dornier Medtech America, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 10 | 0 |
| 2005 | 13 | 0 |
| 2006 | 14 | 0 |
| 2007 | 13 | 0 |
| 2008 | 28 | 0 |
| 2009 | 23 | 0 |
| 2010 | 30 | 0 |
| 2011 | 20 | 0 |
| 2012 | 21 | 0 |
| 2013 | 27 | 0 |
| 2014 | 39 | 0 |
| 2015 | 37 | 0 |
| 2016 | 52 | 0 |
| 2017 | 54 | 0 |
| 2018 | 50 | 0 |
| 2019 | 37 | 0 |
| 2020 | 48 | 0 |
| 2021 | 50 | 0 |
| 2022 | 70 | 0 |
| 2023 | 66 | 0 |
| 2024 | 94 | 0 |
| 2025 | 132 | 0 |
| 2026 | 76 | 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? (8)
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 |
|---|---|---|---|
| * | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970Summary page 1…g and Coagulation Device and name: Accessories (21 CFR 878.4400) B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System 970 K943450, 03/10/95 ArthroCare Bipolar Loop Electrosurgery System K955531, 02/21/96 ArthroCare Urologic Multi-electrode Electrosurgery K… | 1995 |
| * | K955531 | Arthrocare Bipolar Loop Electrode SystemSummary page 1…B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System 970 K943450, 03/10/95 ArthroCare Bipolar Loop Electrosurgery System K955531, 02/21/96 ArthroCare Urologic Multi-electrode Electrosurgery K961069, 05/28/96 System ArthroCare Dental Wand System K962445, 0… | 1996 |
| * | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery SystemSummary page 1…scopic Electrosurgery System 970 K943450, 03/10/95 ArthroCare Bipolar Loop Electrosurgery System K955531, 02/21/96 ArthroCare Urologic Multi-electrode Electrosurgery K961069, 05/28/96 System ArthroCare Dental Wand System K962445, 07/30/96 ArthroCare Electrosurgery System 980 K963123, 10/08/96 Arthro… | 1996 |
| * | K962445 | Arthrocare Dental Electrosurgery SystemSummary page 1…hroCare Bipolar Loop Electrosurgery System K955531, 02/21/96 ArthroCare Urologic Multi-electrode Electrosurgery K961069, 05/28/96 System ArthroCare Dental Wand System K962445, 07/30/96 ArthroCare Electrosurgery System 980 K963123, 10/08/96 ArthroCare General Dermatology Electrosurgery K964849, 04/14/9… | 1996 |
| * | K963123 | Arthrocare Arthroscopic Eletrosurgery System (Model 980)Summary page 1…1/96 ArthroCare Urologic Multi-electrode Electrosurgery K961069, 05/28/96 System ArthroCare Dental Wand System K962445, 07/30/96 ArthroCare Electrosurgery System 980 K963123, 10/08/96 ArthroCare General Dermatology Electrosurgery K964849, 04/14/97 System Conmed Hyfrecator K800617, 05/02/80 K850668,… | 1996 |
| * | K964849 | Arthrocare Dermatologic Electrosurgery SystemSummary page 1…, 05/28/96 System ArthroCare Dental Wand System K962445, 07/30/96 ArthroCare Electrosurgery System 980 K963123, 10/08/96 ArthroCare General Dermatology Electrosurgery K964849, 04/14/97 System Conmed Hyfrecator K800617, 05/02/80 K850668, 05/20/85 C. Device description The ArthroCare Electrosurgery Sy… | 1997 |
| * | K800617 | Hyfrecator, #733Summary page 1…stem K962445, 07/30/96 ArthroCare Electrosurgery System 980 K963123, 10/08/96 ArthroCare General Dermatology Electrosurgery K964849, 04/14/97 System Conmed Hyfrecator K800617, 05/02/80 K850668, 05/20/85 C. Device description The ArthroCare Electrosurgery System is comprised of three components: the P… | 1980 |
| * | K850668 | Electrosurgical Unit 774Summary page 1…/96 ArthroCare Electrosurgery System 980 K963123, 10/08/96 ArthroCare General Dermatology Electrosurgery K964849, 04/14/97 System Conmed Hyfrecator K800617, 05/02/80 K850668, 05/20/85 C. Device description The ArthroCare Electrosurgery System is comprised of three components: the Probe, the Probe Cab… | 1985 |
What descends from it? (1,029)
See all 1,0297 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974521 | Vnus Closure System | 1998 | 977 |
| K023765 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | 2002 | 42 |
| K013139 | Stellartech Coagulation System | 2001 | 42 |
| K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System) | 2002 | 3 |
| K992972 | Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare… | 1999 | 3 |
| K012631 | Reprocessed Soft Tissue Ablators | 2001 | 1 |
| K062539 | Ncontact Coagulation System Kit | 2006 | 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 2 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K974521 (Vnus Medical Technologies, Inc., 1998) has gone furthest, with 977 descendants of its own.
- 10 other devices also cite its predicate K943450.
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 System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.
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/K971532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971532: Arthrocare Electrosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971532
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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