510(k) · Cleared
ClearedArthrocare Arthroscopic Electrosurgery System (Model 970)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · HRX Arthroscope
Cleared on Jul 15, 1996 as substantially equivalent to K943450 (Arthrocare Corp., 1995) after a 70-day review. Its family tree reaches back 1 generation to 1995. 1,326 later devices descend from it.
- Decided
- Jul 15, 1996
- Review
- 70 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943450 (1995). 1,326 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- This deviceK961747 Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp. · 1996
- Descendant · cites it directly · 1,324 of its ownK963123 Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp. · 1996
- 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
- Descendant · 2 generations on · 1,029 of its ownK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
Showing 5 of 1,326 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,326 · See all- K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp. · 1996 · cites it directly1,324descendants
- 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
- K971532Arthrocare Electrosurgery SystemArthrocare Corp. · 1997 · 2 generations on1,029descendants
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) | K961747 | Arthrocare Arthroscopic Electrosurgery System (Model 970) | Arthrocare Corp. | 1996 | — |
| +1 | K963123 | Arthrocare Arthroscopic Eletrosurgery System (Model 980) | Arthrocare Corp. | 1996 | — |
| +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 | — |
| +2 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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…gery to resect soft tissue and provide hemostasis. The System is comprised of three components: the Multi-Electrode Wand, the Wand Cable, and the Controller. The System (K943450) was determined substantially equivalent on March 10, 1995. The bipolar design of the ArthroCare Wand incorporates the return el… | 1995 |
What descends from it? (1,326)
See all 1,3262 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?
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The ArthroCare Arthroscopic Electrosurgery System™ is a high frequency electrosurgical device intended for use in arthroscopic 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/K961747 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961747: Arthrocare Arthroscopic Electrosurgery System (Model 970).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961747
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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