510(k) · Cleared
ClearedPlasmaBlade UPPP and Suction Coagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Advanced Energy · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 21, 2015 as substantially equivalent to K083415 (Peak Surgical, Inc., 2009) and 2 other predicates after a 104-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- May 21, 2015
- Review
- 104 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K936109 (1994). 74 ancestors in all, the oldest K780977 (1978). No later device cites it as a predicate yet.
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations between
- 3 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 2 generations backK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- 1 generation backK103775 Peak Suction CoagulatorPeak Surgical, Inc. · 2011
- This deviceK150297 PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy · 2015
Show all 14 generations
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 13 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 12 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 11 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 10 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 9 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 8 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 6 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 5 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 4 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 3 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 2 generations backK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- 1 generation backK103775 Peak Suction CoagulatorPeak Surgical, Inc. · 2011
- This deviceK150297 PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −13 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −11 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −10 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −9 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −8 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −6 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −5 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −4 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −3 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −2 | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device | Peak Surgical, Inc. | 2009 | — |
| −1 | K103775 | Peak Suction Coagulator | Peak Surgical, Inc. | 2011 | — |
| 0 (this device) | K150297 | PlasmaBlade UPPP and Suction Coagulator | Medtronic Advanced Energy | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DeviceSummary page 5…me: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400) Product Code: GEI Predicate Device: K083415 PEAK PlasmaBlade TnA (Tonsil Tip PS300-001) K014290 (Original) Arthrocare ENT Plasma Wands… | 2009 |
| * | K014290 | Entec Plasma WandsSummary page 5…(21 CFR 878.4400) Product Code: GEI Predicate Device: K083415 PEAK PlasmaBlade TnA (Tonsil Tip PS300-001) K014290 (Original) Arthrocare ENT Plasma Wands K103775 PEAK PlasmaBlade Suction Coagulator Device Description:… | 2002 |
| * | K103775 | Peak Suction CoagulatorSummary page 5…icate Device: K083415 PEAK PlasmaBlade TnA (Tonsil Tip PS300-001) K014290 (Original) Arthrocare ENT Plasma Wands K103775 PEAK PlasmaBlade Suction Coagulator Device Description: The PEAK PlasmaBlade® UPPP and Suction Coagulator is a single-use,… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 74 ancestors have a recall of any class.
- 5 other devices also cite its predicate K083415.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 UPPP is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including, uvulopalatopharyngoplasty (UPPP) and tonsillectomy (Pharyngeal, Tubal, Palatine).
The PEAK PlasmaBlade Suction Coagulator device is intended for use in surgical procedures such as general and otolaryngology (ENT) including, uvulopalatopharyngoplasty (UPPP), tonsillectomy, and adenoidectomy, where coagulation of tissue and suction of fluids are desired. It is not intended to be used as a dissection instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150297 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150297: PlasmaBlade UPPP and Suction Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150297
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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