510(k) Report

510(k) · Cleared

Cleared

Arthrocare Bipolar Electrosurgery System

K031029510(k) TraditionalCleared Jun 19, 200379-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrocare Corp. · FAS Electrode, Electrosurgical, Active, Urological

Cleared on Jun 19, 2003 as substantially equivalent to K955531 (Arthrocare Corp., 1996) and 4 other predicates after a 79-day review. Its family tree reaches back 3 generations to 2000.

Decided
Jun 19, 2003
Review
79 days
Class
Class II
Product code
FAS
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K000778 (2000). 10 ancestors in all, the oldest K955531 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 1 other ancestor2000: 4 other ancestors1996: 1 other ancestorK000778 · Entec Reflex Wand 55, Model E4055-01, E4045-01 · Arthrocare Corp. · 2000K011634 · Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model H2000-04; Powercord, Model H2000 · Arthrocare Corp. · 2001K020832 · Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands · Arthrocare Corp. · 200219961998200020022004
Other ancestors, by generation 1 generation back: 4 other ancestors3 generations back: 3 other ancestors K020832 · Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands · Arthrocare Corp. · 2002K011634 · Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model H2000-04; Powercord, Model H2000 · Arthrocare Corp. · 2001K000778 · Entec Reflex Wand 55, Model E4055-01, E4045-01 · Arthrocare Corp. · 20000
  1. Root · 3 generations backK000778 Entec Reflex Wand 55, Model E4055-01, E4045-01Arthrocare Corp. · 2000
  2. 2 generations backK011634 Arthrocare Controller, Model H2000; Arthrocare Cable, Model…Arthrocare Corp. · 2001
  3. 1 generation backK020832 Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord…Arthrocare Corp. · 2002
  4. This deviceK031029 Arthrocare Bipolar Electrosurgery SystemArthrocare Corp. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000778Entec Reflex Wand 55, Model E4055-01, E4045-01Arthrocare Corp.2000—
−2K011634Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02…Arthrocare Corp.2001—
−1K020832Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, WandsArthrocare Corp.2002—
0 (this device)K031029Arthrocare Bipolar Electrosurgery SystemArthrocare Corp.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200040
200110
200210
FIG. 1 — Lineage of K031029, 2000–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K955531Arthrocare Bipolar Loop Electrode System
Summary page 1
…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare Bipolar Loop Uectrosurgery System K955531,K010568,KO20832 and KO22543 PlasmaKinetic Endourology ( ienerator KO03569 Product Description…
Arthrocare Corp.1996—
*K010568Arthrocare Urology Electrosurgery System
Summary page 1
…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare Bipolar Loop Uectrosurgery System K955531,K010568,KO20832 and KO22543 PlasmaKinetic Endourology ( ienerator KO03569 Product Description l’he Art…
Arthrocare Corp.2001—
*K020832Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, WandsArthrocare Corp.2002—
*K022543Arthrocare Bipolar Electrosurgery SystemArthrocare Corp.2002—
*K003569Plasmakinetic Endourology SystemGyrus Medical, Ltd.2000—

Also cleared against K955531: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 3 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
  • None of the 10 ancestors has a recall.
  • 6 other devices also cite its predicate K955531.

How does its category compare?

All FAS devices

FAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAS

2in 2025

2010: 32011: 12012: 22015: 12016: 12017: 22021: 22022: 12024: 12025: 2
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAS

150in 2010

2010: 150 days median
2007high 150 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FAS

1in 2023

2016: 22021: 42023: 1
2007high 4 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FAS

395in 2025

2007: 62008: 132009: 92010: 252011: 332012: 302013: 482014: 522015: 822016: 692017: 1212018: 702019: 612020: 1002021: 1022022: 1472023: 3292024: 3102025: 395
2007high 395 (2025) · low 6 (2007)2025

MAUDE reports naming product code FAS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—06
20080—013
20090—09
20103150025
20111—033
20122—030
20130—048
20140—052
20151—082
20161—269
20172—0121
20180—070
20190—061
20200—0100
20212—4102
20221—0147
20230—1329
20241—0310
20252—0395
20260—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 tumors of the bladder wall. The System has been shown to be effective in tissue…

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 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.

Also cleared against K955531

6 other devices cite the same predicate.

  • K022543Arthrocare Bipolar Electrosurgery SystemArthrocare Corp. · 2002
  • K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
  • K971532Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  • K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  • K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  • K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996

More from Arthrocare Corp.

112 FDA decisions under this applicant name. See the company

  • K153186Adjustable Fixation DeviceArthrocare Corp. · 2016
  • K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp. · 2013
  • K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp Tipped Obturator…Arthrocare Corp. · 2013
  • K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide…Arthrocare Corp. · 2011
  • K111397Titan TI Suture Anchor SystemArthrocare Corp. · 2011

Recent decisions in FAS

The FAS category page

  • K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use…Dornier Medtech America Inc (Dmta) · 2025
  • K250522Multi4 SystemMulti4 Medical AB · 2025
  • K240504PLASMA EDGE SystemLamidey Noury Medical · 2024
  • K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation · 2022
  • K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 20211 recall

https://510kreport.com/device/K031029 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031029: Arthrocare Bipolar 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/K031029

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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