510(k) Report

510(k) · Cleared

Cleared

Arthrocare Sinus Electrosurgery System

K973478510(k) TraditionalCleared Jan 9, 1998116-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 Jan 9, 1998 as substantially equivalent to K943450 (Arthrocare Corp., 1995) and 7 other predicates after a 116-day review. Its family tree reaches back 4 generations to 1995. 1,219 later devices descend from it.

Decided
Jan 9, 1998
Review
116 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
8

Its longest line of descent runs back 4 generations to K943450 (1995). 14 ancestors in all, the oldest K800617 (1980). 1,219 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 4 other ancestors1995: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1980: 1 other ancestor1998: 1 descendant cleared2002: 7 descendants cleared2003: 16 descendants cleared1999: 1 descendant cleared2001: 4 descendants cleared2006: 10 descendants cleared2016: 68 descendants cleared2015: 54 descendants cleared2013: 46 descendants cleared2007: 16 descendants cleared2010: 35 descendants cleared2004: 9 descendants cleared2019: 45 descendants cleared2025: 133 descendants cleared2000: 2 descendants cleared2005: 18 descendants cleared2008: 37 descendants cleared2022: 84 descendants cleared2012: 31 descendants cleared2009: 27 descendants cleared2014: 43 descendants cleared2011: 25 descendants cleared2020: 61 descendants cleared2018: 56 descendants cleared2021: 65 descendants cleared2023: 79 descendants cleared2017: 66 descendants cleared2026: 82 descendants cleared2024: 98 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors 1 generation forward: 6 descendants2 generations forward: 20 descendants3 generations forward: 36 descendants4 generations forward: 59 descendants5 generations forward: 94 descendants6 generations forward: 165 descendants7 generations forward: 196 descendants8 generations forward: 210 descendants9 generations forward: 182 descendants10 generations forward: 118 descendants11 generations forward: 69 descendants12 generations forward: 38 descendants13 generations forward: 12 descendants14 generations forward: 6 descendants15 generations forward: 2 descendants16 generations forward: 5 descendants17 generations forward: 1 descendant K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 19950+5+10+15
  1. Root · 4 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 3 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 2 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 1 generation backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. This deviceK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. Descendant · cites it directly · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. Descendant · 2 generations on · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. Descendant · 3 generations on · 800 of its ownK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. Descendant · 3 generations on · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. Descendant · 3 generations on · 789 of its ownK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002

Showing 5 of 1,219 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12000: 22001: 42002: 72003: 162004: 92005: 182006: 102007: 162008: 372009: 272010: 352011: 252012: 312013: 462014: 432015: 542016: 682017: 662018: 562019: 452020: 612021: 652022: 842023: 792024: 982025: 1332026: 82
1998high 133 (2025) · low 1 (1998)2026

Most influential descendants

Showing 5 of 1,219 · See all
  • K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · cites it directly1,073descendants
  • K000944Thermage Thermacool SystemThermage, Inc. · 2000 · 2 generations on1,069descendants
  • K013034Modification to: Thermacool IiaThermage, Inc. · 2001 · 3 generations on800descendants
  • K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · 3 generations on799descendants
  • K021402Thermage Thermacool TC SystemThermage, Inc. · 2002 · 3 generations on789descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−3K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−2K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−1K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
0 (this device)K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
+1K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
+2K000944Thermage Thermacool SystemThermage, Inc.2000—
+3K013034Modification to: Thermacool IiaThermage, Inc.2001—
+3K013639Thermage Thermacool TC SystemThermage, Inc.2002—
+3K021402Thermage Thermacool TC SystemThermage, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199220
199410
199520
199640

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200020
200140
200270
2003160
200490
2005180
2006100
2007160
2008370
2009270
2010350
2011250
2012310
2013460
2014430
2015540
2016680
2017660
2018560
2019450
2020610
2021650
2022840
2023790
2024980
20251330
2026820
FIG. 1 — Lineage of K973478, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (8)

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
*K943450Arthrocare Arthroscopic Electrosurgery System Model 970
Summary page 1
…Electrosurgical Cutting and Coagulation Device name: (21 CFR 878.4400) B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System K943450, 03/10/95 ArthroCare Arthroscopic Electrosurgery System 980 K963123, 10/08/96 (Model 2000) ArthroCare Dental Electrosurgery Syst…
Arthrocare Corp.1995—
*K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)
Summary page 1
…0) B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System K943450, 03/10/95 ArthroCare Arthroscopic Electrosurgery System 980 K963123, 10/08/96 (Model 2000) ArthroCare Dental Electrosurgery System K962445, 07/30/96 ArthroCare General Dermatology Electrosurgery…
Arthrocare Corp.1996—
*K962445Arthrocare Dental Electrosurgery System
Summary page 1
…oscopic Electrosurgery System K943450, 03/10/95 ArthroCare Arthroscopic Electrosurgery System 980 K963123, 10/08/96 (Model 2000) ArthroCare Dental Electrosurgery System K962445, 07/30/96 ArthroCare General Dermatology Electrosurgery K964849, 04/14/97 System Stryker Hummer II MicroDebrider System K952681…
Arthrocare Corp.1996—
*K964849Arthrocare Dermatologic Electrosurgery System
Summary page 1
…scopic Electrosurgery System 980 K963123, 10/08/96 (Model 2000) ArthroCare Dental Electrosurgery System K962445, 07/30/96 ArthroCare General Dermatology Electrosurgery K964849, 04/14/97 System Stryker Hummer II MicroDebrider System K952681, 07/20/95 Valleylab Force 2 Electrosurgical Generator K921884, 1…
Arthrocare Corp.1997—
*K952681Stryker Hummer II Microdebrider System
Summary page 1
…ArthroCare Dental Electrosurgery System K962445, 07/30/96 ArthroCare General Dermatology Electrosurgery K964849, 04/14/97 System Stryker Hummer II MicroDebrider System K952681, 07/20/95 Valleylab Force 2 Electrosurgical Generator K921884, 12/92 Coherent Medical Versapulse Laser System K914136 Sharplan CO…
Stryker Endoscopy1995—
*K921884FORCE 2
Summary page 1
…hroCare General Dermatology Electrosurgery K964849, 04/14/97 System Stryker Hummer II MicroDebrider System K952681, 07/20/95 Valleylab Force 2 Electrosurgical Generator K921884, 12/92 Coherent Medical Versapulse Laser System K914136 Sharplan CO2 Surgical Laser K933362 C. Device description The AccENT He…
Valleylab, Inc.1992—
*K914136Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase
Summary page 1
…4/97 System Stryker Hummer II MicroDebrider System K952681, 07/20/95 Valleylab Force 2 Electrosurgical Generator K921884, 12/92 Coherent Medical Versapulse Laser System K914136 Sharplan CO2 Surgical Laser K933362 C. Device description The AccENT Head and Neck Electrosurgery System is comprised of three…
Coherent Medical Group1992—
*K933362Sharplan CO2 Surgical Laser
Summary page 1
…Debrider System K952681, 07/20/95 Valleylab Force 2 Electrosurgical Generator K921884, 12/92 Coherent Medical Versapulse Laser System K914136 Sharplan CO2 Surgical Laser K933362 C. Device description The AccENT Head and Neck Electrosurgery System is comprised of three components: the AccENT Wand, the Acc…
Laser Industries, Ltd.1994—

Also cleared against K943450: 10 other devices →

What descends from it? (1,219)

See all 1,219

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

NumberDeviceApplicantDecidedDescendants
K981870Visage Cosmetic Surgery SystemArthrocare Corp.19981,073
K014290Entec Plasma WandsArthrocare Corp.2002119
K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276
K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Arthrocare Corp.199923
K032838Celon Ent SystemCelon AG Medical Instruments20033
K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011

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 9 months on median.
  • 1 of the 14 ancestors has a recall of any class.
  • Of its descendants, K981870 (Arthrocare Corp., 1998) has gone furthest, with 1,073 descendants of its own.
  • 10 other devices also cite its predicate K943450.

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

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
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

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The AccENT Head and Neck Electrosurgery System is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K943450

10 other devices cite the same predicate.

  • K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
  • K992805Oratec Ablator-S Probes (Monopolar Ablation Suction Probes)Oratec Interventions, Inc. · 2000
  • K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, ArthrowandsArthrocare Corp. · 1999
  • K971532Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  • K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  • K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare 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 GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K973478 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973478: Arthrocare Sinus Electrosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973478

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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