510(k) · Cleared
ClearedArthrocare Dermatologic 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 Apr 14, 1997 as substantially equivalent to K943450 (Arthrocare Corp., 1995) and 4 other predicates after a 132-day review. Its family tree reaches back 3 generations to 1995. 1,322 later devices descend from it.
- Decided
- Apr 14, 1997
- Review
- 132 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K943450 (1995). 6 ancestors in all, the oldest K800617 (1980). 1,322 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 2 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 1 generation backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- This deviceK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- Descendant · cites it directly · 1,219 of its ownK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- Descendant · cites it directly · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- Descendant · 2 generations on · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- Descendant · cites it directly · 1,029 of its ownK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- Descendant · 2 generations on · 977 of its ownK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
Showing 5 of 1,322 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,322 · See all- K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998 · cites it directly1,219descendants
- K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · cites it directly1,073descendants
- K000944Thermage Thermacool SystemThermage, Inc. · 2000 · 2 generations on1,069descendants
- K971532Arthrocare Electrosurgery SystemArthrocare Corp. · 1997 · cites it directly1,029descendants
- K974521Vnus Closure SystemVnus Medical Technologies, Inc. · 1998 · 2 generations on977descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −2 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −1 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| 0 (this device) | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| +1 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| +1 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| +2 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| +1 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| +2 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 14 | 0 |
| 2003 | 23 | 0 |
| 2004 | 16 | 0 |
| 2005 | 20 | 0 |
| 2006 | 18 | 0 |
| 2007 | 21 | 0 |
| 2008 | 44 | 0 |
| 2009 | 31 | 0 |
| 2010 | 40 | 0 |
| 2011 | 28 | 0 |
| 2012 | 35 | 0 |
| 2013 | 47 | 0 |
| 2014 | 48 | 0 |
| 2015 | 56 | 0 |
| 2016 | 73 | 0 |
| 2017 | 69 | 0 |
| 2018 | 59 | 0 |
| 2019 | 49 | 0 |
| 2020 | 62 | 0 |
| 2021 | 68 | 0 |
| 2022 | 85 | 0 |
| 2023 | 81 | 0 |
| 2024 | 101 | 0 |
| 2025 | 136 | 0 |
| 2026 | 84 | 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 |
|---|---|---|---|
| * | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970Summary page 1…Cutting and Coagulation Device and name: Accessories (21 CFR 878.4400) B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System K943450 ArthroCare Dental Electrosurgery System K962445 ArthroCare Bipolar Loop Electrosurgery System K955531 ArthroCare Urologic Multi-e… | 1995 |
| * | K962445 | Arthrocare Dental Electrosurgery SystemSummary page 1…ries (21 CFR 878.4400) B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System K943450 ArthroCare Dental Electrosurgery System K962445 ArthroCare Bipolar Loop Electrosurgery System K955531 ArthroCare Urologic Multi-electrode Electrosurgery K961069 |> System ConM… | 1996 |
| * | K955531 | Arthrocare Bipolar Loop Electrode SystemSummary page 1…emarket Notification ArthroCare Arthroscopic Electrosurgery System K943450 ArthroCare Dental Electrosurgery System K962445 ArthroCare Bipolar Loop Electrosurgery System K955531 ArthroCare Urologic Multi-electrode Electrosurgery K961069 |> System ConMed Hyfrecator Plus K800617 C. Device description The… | 1996 |
| * | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery SystemSummary page 1…System K943450 ArthroCare Dental Electrosurgery System K962445 ArthroCare Bipolar Loop Electrosurgery System K955531 ArthroCare Urologic Multi-electrode Electrosurgery K961069 |> System ConMed Hyfrecator Plus K800617 C. Device description The ArthroCare Dermal Electrosurgery System is comprised of thr… | 1996 |
| * | K800617 | Hyfrecator, #733Summary page 1…urgery System K962445 ArthroCare Bipolar Loop Electrosurgery System K955531 ArthroCare Urologic Multi-electrode Electrosurgery K961069 |> System ConMed Hyfrecator Plus K800617 C. Device description The ArthroCare Dermal Electrosurgery System is comprised of three components: the Dermal Handpiece with C… | 1980 |
What descends from it? (1,322)
See all 1,3225 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 2 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K973478 (Arthrocare Corp., 1998) has gone furthest, with 1,219 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 Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.
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/K964849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964849: Arthrocare Dermatologic Electrosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964849
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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