510(k) · Cleared

Cleared

Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands

K020621510(k) SpecialCleared Mar 28, 200230-day reviewClass I21 CFR 878.4820

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

Arthrocare Corp. · GEY Motor, Surgical Instrument, Ac-Powered

Cleared on Mar 28, 2002 as substantially equivalent to K010811 (Arthrocare Corp., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 33 later devices descend from it.

Decided: Mar 28, 2002
Review: 30 days
Class: Class I
Product code: GEY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010811 (2001). 33 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK010811 Perc-D SpinewandArthrocare Corp. · 2001
This deviceK020621 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
Descendant · cites it directly · 32 of its ownK030954 Arthrocare Percd SpinewandArthrocare Corp. · 2003
Descendant · 2 generations on · 24 of its ownK040338 Arthrocare Controller, Cable, Foot Control, Power Cord, Wands…Arthrocare Corp. · 2004
Descendant · 3 generations on · 21 of its ownK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
Descendant · 4 generations on · 20 of its ownK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
Descendant · 5 generations on · 19 of its ownK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2003high 5 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 33 · See all

K030954Arthrocare Percd SpinewandArthrocare Corp. · 2003 · cites it directly32descendants
K040338Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02…Arthrocare Corp. · 2004 · 2 generations on24descendants
K071963Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 3 generations on21descendants
K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 4 generations on20descendants
K082323Arthrocare ArthrowandsArthrocare Corp. · 2008 · 5 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010811	Perc-D Spinewand	Arthrocare Corp.	2001	—
0 (this device)	K020621	Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands	Arthrocare Corp.	2002	—
+1	K030954	Arthrocare Percd Spinewand	Arthrocare Corp.	2003	—
+2	K040338	Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models…	Arthrocare Corp.	2004	—
+3	K071963	Modification to: Arthrocare Arthrowands	Arthrocare Corp.	2007	—
+4	K072865	Modificaton to: Arthrocare Arthrowands	Arthrocare Corp.	2007	—
+5	K082323	Arthrocare Arthrowands	Arthrocare Corp.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	1	0
2006	1	0
2007	3	0
2008	3	0
2009	4	0
2010	1	0
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2016	5	0
2017	2	0
2018	2	0
2019	1	0
2023	1	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K020621, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K010811	Perc-D Spinewand Summary page 1 …736-0224 February 25, 2002 Perc-D™ SpineWand™ Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) K010811; cleared on May 30, 2001 The Wands are bipolar, single use, high frequency electrosurgical devices. Intended Use The Perc-D Sp…	Arthrocare Corp.	2001	—

Also cleared against K010811: 4 other devices →

What descends from it? (33)

See all 33

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030954	Arthrocare Percd Spinewand	Arthrocare Corp.	2003	32
K100353	Spinewand Surgical Device	Arthrocare Corp.	2010	3

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?

Its one ancestor has no recall.
Of its descendants, K030954 (Arthrocare Corp., 2003) has gone furthest, with 32 descendants of its own.
4 other devices also cite its predicate K010811.

How does its category compare?

All GEY devices

GEY Motor, Surgical Instrument, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEY

FDA has decided no GEY device since 2007.

Median 510(k) review, days · GEY

Too few GEY 510(k)s in any year since 2007 to give a median.

Recalls per year · GEY

2in 2013

2007high 2 (2013) · low 0 (2007)2026

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

Adverse event reports per year · GEY

965in 2025

2007high 2,119 (2017) · low 4 (2009)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	19
2008	—	1	9
2009	—	1	4
2010	—	0	4
2011	—	0	11
2012	—	1	14
2013	—	2	901
2014	—	0	738
2015	—	0	2,013
2016	—	0	1,943
2017	—	0	2,119
2018	—	0	1,288
2019	—	0	1,131
2020	—	0	952
2021	—	0	1,145
2022	—	0	1,360
2023	—	0	1,444
2024	—	0	1,447
2025	—	0	965
2026	—	0	—

What is it indicated for?

The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of

disc material to treat symptomatic patients with contained herniated discs.

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/K020621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020621: Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020621

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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