510(k) · Cleared
ClearedPeak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peak Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 5, 2009 as substantially equivalent to K073057 (Peak Surgical, Inc., 2008) and 1 other predicate after a 199-day review. Its family tree reaches back 12 generations to 1994. 8 later devices descend from it.
- Decided
- Jun 5, 2009
- Review
- 199 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K936109 (1994). 69 ancestors in all, the oldest K780977 (1978). 8 later devices descend from it, 6 citing it directly.
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations between
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK121678 DTADGyrus Acmi, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK103775 Peak Suction CoagulatorPeak Surgical, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK152703 PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy · 2016
Show all 12 generations
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 10 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 9 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 8 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 7 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 6 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 5 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 4 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K121678DTADGyrus Acmi, Inc. · 2012 · cites it directly2descendants
- K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · 2 generations on1descendant
- K103775Peak Suction CoagulatorPeak Surgical, Inc. · 2011 · cites it directly1descendant
- K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022 · 3 generations on0descendants
- K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −11 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −9 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −8 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −7 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −6 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −5 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −3 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −2 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −1 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| 0 (this device) | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device | Peak Surgical, Inc. | 2009 | — |
| +1 | K121678 | DTAD | Gyrus Acmi, Inc. | 2012 | — |
| +2 | K123429 | Olympus Energy Power System (Eps) | Gyrus Acmi, Inc. | 2013 | 12 |
| +1 | K103775 | Peak Suction Coagulator | Peak Surgical, Inc. | 2011 | — |
| +3 | K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022 | — |
| +1 | K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | Medtronic Advanced Energy | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2022 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K073057 | Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Summary page 1…d Accessories (21 CFR 878.4400) 3. Predicate Devices: PEAK PlasmaBladeTm Tissue Dissection Device (K073057) ArthroCare® ENT Plasma WandsTM (K070374) 4. Device description: The PEAK Plasm… | 2008 |
| * | K070374 | Arthrocare Ent Plasma WandSummary page 1…R 878.4400) 3. Predicate Devices: PEAK PlasmaBladeTm Tissue Dissection Device (K073057) ArthroCare® ENT Plasma WandsTM (K070374) 4. Device description: The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device… | 2007 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121678 | DTAD | 2012 | 2 |
| K103775 | Peak Suction Coagulator | 2011 | 1 |
| K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | 2016 | 0 |
| K152702 | Ent Biotech Solutions Tissue Removal Device (Elasso) | 2016 | 0 |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | 2015 | 0 |
| K102709 | Peak Plasmablade Plus Tissue Dissection Device | 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 15 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 69 ancestors have a recall of any class.
- Of its descendants, K121678 (Gyrus Acmi, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K073057.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is only indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083415: Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083415
Report an extraction error
Are you the manufacturer?
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