510(k) · Cleared

Cleared

Arthrocare 8000S Coblator Surgery System

K053297510(k) SpecialCleared Dec 6, 200511-day reviewClass II21 CFR 878.4400

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

Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 6, 2005 as substantially equivalent to K001588 (Arthrocare Corp., 2000) after an 11-day review. Its family tree reaches back 1 generation to 2000. 19 later devices descend from it.

Decided: Dec 6, 2005
Review: 11 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001588 (2000). 19 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK001588 Arthrocare System 2000 Controller, Arthrocare System 2000 Cable…Arthrocare Corp. · 2000
This deviceK053297 Arthrocare 8000S Coblator Surgery SystemArthrocare Corp. · 2005
Descendant · cites it directly · 16 of its ownK060823 Arthrocare WandsArthrocare Corp. · 2006
Descendant · 2 generations on · 12 of its ownK063172 Arthrocare Cavity SpinewandArthrocare Corp. · 2007 · Recalled
Descendant · 3 generations on · 11 of its ownK091310 Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model…Dfine, Inc. · 2010
Descendant · 4 generations on · 9 of its ownK142480 OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015
Descendant · 5 generations on · 8 of its ownK152057 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2006high 3 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 19 · See all

K060823Arthrocare WandsArthrocare Corp. · 2006 · cites it directly16descendants
K063172Arthrocare Cavity SpinewandArthrocare Corp. · 2007 · 2 generations on12descendants
K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc. · 2010 · 3 generations on11descendants
K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015 · 4 generations on9descendants
K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015 · 5 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001588	Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare…	Arthrocare Corp.	2000	—
0 (this device)	K053297	Arthrocare 8000S Coblator Surgery System	Arthrocare Corp.	2005	—
+1	K060823	Arthrocare Wands	Arthrocare Corp.	2006	—
+2	K063172	Arthrocare Cavity Spinewand	Arthrocare Corp.	2007	1
+3	K091310	Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682	Dfine, Inc.	2010	—
+4	K142480	OsteoCool V-2 RF Ablation System	Baylis Medical Company, Inc.	2015	—
+5	K152057	OsteoCool V-3 RF Ablation System	Baylis Medical Company, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	3	0
2009	1	0
2010	2	0
2012	1	0
2013	1	0
2015	2	0
2017	1	0
2019	1	0
2020	1	0
2022	1	0
2023	1	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K053297, 2000–2026Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K001588	Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000… Summary page 1 …ing and Coagulation Device and Accessories (21 CER 878.4400) Predicate Devices ArflhroCare®~ System K001 588 2000 Product Description The ArthroCare SOOOS Coblator Surgery System is a bipolar, high frequency electrosurgical system consis…	Arthrocare Corp.	2000	—

Also cleared against K001588: 7 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K060823	Arthrocare Wands	Arthrocare Corp.	2006	16
K091674	Arthrocare Coblator IQ System	Arthrocare Corp.	2010	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?

Its one ancestor has no recall.
Of its descendants, K060823 (Arthrocare Corp., 2006) has gone furthest, with 16 descendants of its own.
7 other devices also cite its predicate K001588.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The ArthroCare 8000S Coblator Surgery System is intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroseopic, spinal, and neurological procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053297 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053297: Arthrocare 8000S Coblator Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053297

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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