510(k) · Cleared
ClearedArthrocare Bipolar 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 Aug 30, 2002 as substantially equivalent to K955531 (Arthrocare Corp., 1996) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Aug 30, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955531 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K031029Arthrocare Bipolar Electrosurgery SystemArthrocare Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955531 | Arthrocare Bipolar Loop Electrode System | Arthrocare Corp. | 1996 | — |
| 0 (this device) | K022543 | Arthrocare Bipolar Electrosurgery System | Arthrocare Corp. | 2002 | — |
| +1 | K031029 | Arthrocare Bipolar Electrosurgery System | Arthrocare Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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 |
|---|---|---|---|
| * | K955531 | Arthrocare Bipolar Loop Electrode SystemSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCarewBipolar Loop Electrosurgery System K95553 1 and KO1 0568 Product Description The ArthroCare@Bipolar Loop Electrosurgery System is a bipolar, high frequency electrosurgical… | 1996 |
| * | K010568 | Arthrocare Urology Electrosurgery System | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031029 | Arthrocare Bipolar Electrosurgery System | 2003 | 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?
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@Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUP), as well as non-malignant tumors of the bladder wall. The System has been shown to be effective…
Read the full statement (101 words)
The ArthroCare@Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUP), as well as non-malignant tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution, Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022543 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022543: Arthrocare Bipolar Electrosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022543
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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