510(k) · Cleared
ClearedArthrocare Arthroscopic Eletrosurgery System (Model 980)
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 8, 1996 as substantially equivalent to K943450 (Arthrocare Corp., 1995) and 2 other predicates after a 57-day review. Its family tree reaches back 2 generations to 1995. 1,324 later devices descend from it.
- Decided
- Oct 8, 1996
- Review
- 57 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K943450 (1995). 3 ancestors in all. 1,324 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 1 generation backK961747 Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp. · 1996
- This deviceK963123 Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp. · 1996
- 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 1,324 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,324 · 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 |
|---|---|---|---|---|---|
| −2 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −1 | K961747 | Arthrocare Arthroscopic Electrosurgery System (Model 970) | Arthrocare Corp. | 1996 | — |
| 0 (this device) | K963123 | Arthrocare Arthroscopic Eletrosurgery System (Model 980) | Arthrocare Corp. | 1996 | — |
| +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 |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 14 | 0 |
| 2003 | 24 | 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? (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 |
|---|---|---|---|
| * | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970Summary page 1…ies (21 CFR 878.4400) Accessory to an Arthroscope (21 CFR 888.1100 B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System 970 K943450 ArthroCare Arthroscopic Electrosurgery System 970 K961747 (Addition of Hip Indication) ArthroCare Arthroscopic Electrosurgery S… | 1995 |
| * | K961747 | Arthrocare Arthroscopic Electrosurgery System (Model 970)Summary page 1…888.1100 B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System 970 K943450 ArthroCare Arthroscopic Electrosurgery System 970 K961747 (Addition of Hip Indication) ArthroCare Arthroscopic Electrosurgery System 970 K962321 (Addition of Wrist Indication) C. Device… | 1996 |
| * | K962321 | Arthocare Arthroscopic Electrosurgery System Model 970Summary page 1…ctrosurgery System 970 K943450 ArthroCare Arthroscopic Electrosurgery System 970 K961747 (Addition of Hip Indication) ArthroCare Arthroscopic Electrosurgery System 970 K962321 (Addition of Wrist Indication) C. Device description The ArthroCare Arthroscopic Electrosurgery System 980 is comprised of thre… | 1996 |
What descends from it? (1,324)
See all 1,3246 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973478 | Arthrocare Sinus Electrosurgery System | 1998 | 1,219 |
| K981870 | Visage Cosmetic Surgery System | 1998 | 1,073 |
| K971532 | Arthrocare Electrosurgery System | 1997 | 1,029 |
| K992581 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands… | 1999 | 23 |
| K012631 | Reprocessed Soft Tissue Ablators | 2001 | 1 |
| K993009 | Hydrocision Arthrojet System with Cautery | 1999 | 1 |
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 1 year and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- 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 Arthroscopic Electrosurgery System 980 is intended for use in arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, hip and wrist for soft tissue resection and hemostasis.
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/K963123 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963123: Arthrocare Arthroscopic Eletrosurgery System (Model 980).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963123
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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