510(k) · Cleared

Recalled · Class II · 2015

Arthrocare Ent Coblator Surgery System

K030108510(k) SpecialCleared Feb 3, 200321-day reviewClass II21 CFR 878.4400Recalls 1

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 Feb 3, 2003 as substantially equivalent to K021364 (Arthrocare Corp., 2002) after a 21-day review. Its family tree reaches back 8 generations to 1994. 92 later devices descend from it. It has been recalled once.

Decided: Feb 3, 2003
Review: 21 days
Class: Class II
Product code: GEI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 8 generations to K936109 (1994). 53 ancestors in all, the oldest K800617 (1980). 92 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
4 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
3 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
2 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
1 generation backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
This deviceK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003
Descendant · cites it directly · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
Descendant · 2 generations on · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
Descendant · 3 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
Descendant · cites it directly · 42 of its ownK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
Descendant · 4 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2003high 9 (2013) · low 0 (2005)2026

Most influential descendants

Showing 5 of 92 · See all

K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · cites it directly50descendants
K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 2 generations on44descendants
K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 3 generations on42descendants
K033257Arthrocare Ent Plasma WandsArthrocare Corp. · 2003 · cites it directly42descendants
K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on41descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K936109	Sharplan Model 1120 CO2 Surgical Laser	Sharplan Lasers, Inc.	1994	—
−7	K960521	Sharplan Lasers, Inc. Silktouch Flash Scanner	Sharplan Lasers, Inc.	1996	—
−6	K963339	Coherent Ultrapulse CO2 Surgical Lasers	Coherent Medical Group	1997	—
−5	K974789	Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L	Lumenis, Inc.	1998	—
−4	K990947	Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…	Lumenis, Inc.	1999	—
−3	K011703	Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…	Lumenis	2001	2
−2	K014290	Entec Plasma Wands	Arthrocare Corp.	2002	—
−1	K021364	Modification to Entec Plasma Wands	Arthrocare Corp.	2002	—
0 (this device)	K030108	Arthrocare Ent Coblator Surgery System	Arthrocare Corp.	2003	—
+1	K034004	Diego RF Powered Dissector and Drill System Console	Gyrus Ent LLC	2004	—
+2	K072302	Entellus Medical RS-Series System	Entellus Medical, Inc.	2008	—
+3	K081542	Modification to Entellus Medical RS-Series System	Entellus Medical, Inc.	2008	—
+1	K033257	Arthrocare Ent Plasma Wands	Arthrocare Corp.	2003	—
+4	K093007	Entellus Medical Balloon Device	Entellus Medical, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1986	1	0
1989	1	0
1990	1	0
1991	3	0
1992	3	0
1993	1	0
1994	4	0
1995	7	0
1996	8	0
1997	2	0
1998	6	0
1999	1	0
2000	5	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2006	2	0
2007	1	0
2008	3	0
2009	1	0
2010	6	0
2011	6	0
2012	7	0
2013	9	0
2014	4	0
2015	7	0
2016	8	0
2017	5	0
2018	5	0
2019	3	0
2020	6	0
2021	3	0
2022	2	0
2023	6	0
2025	1	0
2026	5	0

FIG. 1 — Lineage of K030108, 1994–2026Source: 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

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
*	K021364	Modification to Entec Plasma Wands	Arthrocare Corp.	2002	—

Also cleared against K021364: 1 other device →

What descends from it? (92)

See all 92

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

Number	Device	Applicant	Decided	Descendants
K034004	Diego RF Powered Dissector and Drill System Console	Gyrus Ent LLC	2004	50
K033257	Arthrocare Ent Plasma Wands	Arthrocare Corp.	2003	42
K100597	Harmonic Focus Shears	Ethicon Endo-Surgery, LLC	2010	18
K192027	WEREWOLF COBLATION System, COBLATION HALO Wand	ArthroCare Corporation	2019	3
K202006	ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…	ArthroCare Corporation	2020	2
K091674	Arthrocare Coblator IQ System	Arthrocare Corp.	2010	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 20, 2015	Class II	Z-1323-2015	Packaging process control	The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E).

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
2 of the 53 ancestors have a recall of any class.
Of its descendants, K034004 (Gyrus Ent LLC, 2004) has gone furthest, with 50 descendants of its own.
1 other device also cites its predicate K021364.

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 ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

Adenoidectomy

CY-

Head, Neck, Oral, and Sinus Surgery

Mastoidectomy

Myringotomy with Effective Hemorrhage Control

Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates

NasopharyngeaKaryngeaI indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking

Neck Mass

Papilloma Keloids

Submucosal Palatal Shrinkage

Submucosal Tissue Shrinkage

Tonsillectomy

Traditional Uvulopalatoplasty (RAUP)

Tumors

Tissue in the UvuldSoft Palate for the Treatment of Snoring

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030108 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030108: Arthrocare Ent Coblator Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030108

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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