510(k) · Cleared
ClearedEntec Plasma Wands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 28, 2002 as substantially equivalent to K973478 (Arthrocare Corp., 1998) and 8 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1994. 119 later devices descend from it.
- Decided
- Mar 28, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K936109 (1994). 51 ancestors in all, the oldest K800617 (1980). 119 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 4 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 3 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 2 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 1 generation backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- This deviceK014290 Entec Plasma WandsArthrocare Corp. · 2002
- Descendant · cites it directly · 94 of its ownK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- Descendant · 2 generations on · 92 of its ownK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 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
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K021364Modification to Entec Plasma WandsArthrocare Corp. · 2002 · cites it directly94descendants
- K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · 2 generations on92descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −5 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −3 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −2 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −1 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| 0 (this device) | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| +1 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| +2 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| +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 | — |
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 |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 11 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 0 |
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
What was it cleared against? (9)
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 | Decided |
|---|---|---|---|
| * | K973478 | Arthrocare Sinus Electrosurgery SystemSummary page 1…s ENTec Coblator™ Plasma Surgery System Somnus Somnoplasty System Ethicon PowerStar Bipolar Scissors Ellman Surgitron IEC II Device and Accessories (21 CFR 878.4400) K973478, K000036, K000778, and K011279 K982717 K981361 K001253 Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:Y… | 1998 |
| * | K000036 | Entec Reflex Wand 55, Model E4055-00Summary page 1…Coblator™ Plasma Surgery System Somnus Somnoplasty System Ethicon PowerStar Bipolar Scissors Ellman Surgitron IEC II Device and Accessories (21 CFR 878.4400) K973478, K000036, K000778, and K011279 K982717 K981361 K001253 Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC… | 2000 |
| * | K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01Summary page 1…Plasma Surgery System Somnus Somnoplasty System Ethicon PowerStar Bipolar Scissors Ellman Surgitron IEC II Device and Accessories (21 CFR 878.4400) K973478, K000036, K000778, and K011279 K982717 K981361 K001253 Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC) Surgica… | 2000 |
| * | K011279 | Entec Evac Plasma WandSummary page 1…ry System Somnus Somnoplasty System Ethicon PowerStar Bipolar Scissors Ellman Surgitron IEC II Device and Accessories (21 CFR 878.4400) K973478, K000036, K000778, and K011279 K982717 K981361 K001253 Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC) Surgical Lasers Medt… | 2001 |
| * | K982717 | Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200Summary page 1…m Somnus Somnoplasty System Ethicon PowerStar Bipolar Scissors Ellman Surgitron IEC II Device and Accessories (21 CFR 878.4400) K973478, K000036, K000778, and K011279 K982717 K981361 K001253 Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC) Surgical Lasers Medtronic Xo… | 1998 |
| * | K981361 | Powerstar Bipolar ScissorsSummary page 1…s Somnoplasty System Ethicon PowerStar Bipolar Scissors Ellman Surgitron IEC II Device and Accessories (21 CFR 878.4400) K973478, K000036, K000778, and K011279 K982717 K981361 K001253 Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC) Surgical Lasers Medtronic Xomed Mono… | 1998 |
| * | K001253 | Surgitron Iec IISummary page 1…lasty System Ethicon PowerStar Bipolar Scissors Ellman Surgitron IEC II Device and Accessories (21 CFR 878.4400) K973478, K000036, K000778, and K011279 K982717 K981361 K001253 Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC) Surgical Lasers Medtronic Xomed Monopolar En… | 2000 |
| * | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Summary page 1…PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC) Surgical Lasers Medtronic Xomed Monopolar Energized Blade 680 Vaqueros Avenuc * Suanyvale, CA 94085 = K011703 K 002987 (408) 736-0224 Fax: (408) 736-0226 Intended Use _ ) The ENTec Plasma Wands are indicated for ablation… | 2001 |
| * | K002987 | Redtronic Xomed Monopolar Energized BladeSummary page 1…te Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC) Surgical Lasers Medtronic Xomed Monopolar Energized Blade 680 Vaqueros Avenuc * Suanyvale, CA 94085 = K011703 K 002987 (408) 736-0224 Fax: (408) 736-0226 Intended Use _ ) The ENTec Plasma Wands are indicated for ablation, resectio… | 2000 |
What descends from it? (119)
See all 1197 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021364 | Modification to Entec Plasma Wands | 2002 | 94 |
| K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | 2002 | 76 |
| K070374 | Arthrocare Ent Plasma Wand | 2007 | 39 |
| K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | 2016 | 0 |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | 2015 | 0 |
| K123353 | Ciq Controller, Ciq Wands | 2013 | 0 |
| K100543 | Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01 | 2010 | 0 |
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 8 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 51 ancestors have a recall of any class.
- Of its descendants, K021364 (Arthrocare Corp., 2002) has gone furthest, with 94 descendants of its own.
- 5 other devices also cite its predicate K973478.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 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 ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
Adenoidectomy
Cysts
Head, Neck, Oral, and Sinus Surgery
Mastoidectomy
Myringotomy with Effective Hemorrhage Control
Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
Nasopharyngeal/Laryngeal 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 Uvula/Soft Palate for the Treatment of Snoring
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/K014290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014290: Entec Plasma Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014290
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026