510(k) · Cleared

Cleared

Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma Wand

K000228510(k) SpecialCleared Feb 22, 200026-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 Feb 22, 2000 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 79 later devices descend from it.

Decided: Feb 22, 2000
Review: 26 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

79 later devices descend from it, 2 citing it directly.

This deviceK000228 Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma…Arthrocare Corp. · 2000
Descendant · cites it directly · 76 of its ownK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
Descendant · 2 generations on · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
Descendant · 3 generations on · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
Descendant · 4 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
Descendant · 5 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2001high 8 (2012) · low 0 (2003)2026

Most influential descendants

Showing 5 of 79 · See all

K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC · 2002 · cites it directly76descendants
K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · 2 generations on50descendants
K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 3 generations on44descendants
K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 4 generations on42descendants
K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 5 generations on41descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000228	Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma Wand	Arthrocare Corp.	2000	—
+1	K021777	Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…	Gyrus Ent LLC	2002	—
+2	K034004	Diego RF Powered Dissector and Drill System Console	Gyrus Ent LLC	2004	—
+3	K072302	Entellus Medical RS-Series System	Entellus Medical, Inc.	2008	—
+4	K081542	Modification to Entellus Medical RS-Series System	Entellus Medical, Inc.	2008	—
+5	K093007	Entellus Medical Balloon Device	Entellus Medical, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2004	3	0
2005	2	0
2006	1	0
2008	7	0
2009	1	0
2010	3	0
2011	6	0
2012	8	0
2013	8	0
2014	4	0
2015	6	0
2016	7	0
2017	4	0
2018	2	0
2019	1	0
2020	3	0
2021	2	0
2022	3	0
2023	5	0
2026	1	0

FIG. 1 — Lineage of K000228, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (79)

See all 79

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

Number	Device	Applicant	Decided	Descendants
K021777	Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…	Gyrus Ent LLC	2002	76
K012631	Reprocessed Soft Tissue Ablators	Alliance Medical Corp.	2001	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?

Of its descendants, K021777 (Gyrus Ent LLC, 2002) has gone furthest, with 76 descendants of its own.

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	—

https://510kreport.com/device/K000228 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000228: Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000228

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026