510(k) · Cleared
ClearedArthrocare Urologic Multi-Electrode Electrosurgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · FAS Electrode, Electrosurgical, Active, Urological
Cleared on May 28, 1996 as substantially equivalent to K943450 (Arthrocare Corp., 1995) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1995. 1,326 later devices descend from it.
- Decided
- May 28, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943450 (1995). 2 ancestors in all. 1,326 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- This deviceK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- Descendant · cites it directly · 1,325 of its ownK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- Descendant · cites it directly · 1,322 of its ownK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- Descendant · 2 generations on · 1,219 of its ownK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- Descendant · 2 generations on · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- Descendant · 3 generations on · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
Showing 5 of 1,326 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,326 · See all- K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996 · cites it directly1,325descendants
- K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997 · cites it directly1,322descendants
- K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998 · 2 generations on1,219descendants
- K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · 2 generations on1,073descendants
- K000944Thermage Thermacool SystemThermage, Inc. · 2000 · 3 generations on1,069descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| 0 (this device) | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| +1 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| +1 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| +2 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| +2 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| +3 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 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 FAS? 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 FAS device
- #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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…troller. The UroWand, UroWand Cable and the Controlier are virtually identical to the ArthroCare Probe, Probe Cable and Controller determined substantially equivalent in K943450 for the ArthroCare Arthroscopic Electrosurgery System. The technology is also substantially equivalent to that of the ArthroCare… | 1995 |
| * | K955531 | Arthrocare Bipolar Loop Electrode SystemSummary page 1…n K943450 for the ArthroCare Arthroscopic Electrosurgery System. The technology is also substantially equivalent to that of the ArthroCare Bipolar Loop Electrode System (K955531). Predicate electrode products and electrosurgical generators have been marketed since the 1950’s by several different manufactu… | 1996 |
What descends from it? (1,326)
See all 1,3265 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962445 | Arthrocare Dental Electrosurgery System | 1996 | 1,325 |
| K964849 | Arthrocare Dermatologic Electrosurgery System | 1997 | 1,322 |
| K971532 | Arthrocare Electrosurgery System | 1997 | 1,029 |
| K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System) | 2002 | 3 |
| K012631 | Reprocessed Soft Tissue Ablators | 2001 | 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?
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 2025
MAUDE reports naming product code FAS, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 3 | 150 | 0 | 25 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 2 | 69 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 61 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 2 | — | 4 | 102 |
| 2022 | 1 | — | 0 | 147 |
| 2023 | 0 | — | 1 | 329 |
| 2024 | 1 | — | 0 | 310 |
| 2025 | 2 | — | 0 | 395 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ArthroCare Urologic Multi-electrode Electrosurgery System is a high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide 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/K961069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961069: Arthrocare Urologic Multi-Electrode 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/K961069
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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