Devices descending from K001253
220 later devices reach Surgitron Iec II through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +5 | K170758 | Thermage FLX System and Accessories | Solta Medical | 2017 | 13 | — |
| +5 | K171262 | TempSure | Cynosure, Inc. | 2017 | 16 | — |
| +5 | K170908 | PK AIM | Gyrus Acmi, Inc. | 2017 | 0 | — |
| +5 | K170610 | PlasmaBlade T | Medtronic Advanced Energy | 2017 | 0 | — |
| +5 | K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Stryker Sustainability Solutions | 2017 | 0 | 1 |
| +5 | K170116 | Thermi Injectable RF Electrodes | Thermi | 2017 | 2 | — |
| +5 | K163190 | InMode RF System | Inmode MD, Ltd. | 2016 | 0 | — |
| +5 | K161038 | PK Morcellator | Gyrus Acmi, Inc. | 2016 | 0 | — |
| +5 | K162053 | PhotonBlade | Invuity, Inc. | 2016 | 1 | 1 |
| +5 | K153371 | Sonicision Cordless Ultrasonic Dissection Device | Covidien, LLC | 2016 | 4 | — |
| +5 | K150524 | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology | Surgical Instrument Services and Savings, Inc. | 2015 | 0 | — |
| +5 | K151340 | HARMONIC Focus Long Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2015 | 0 | — |
| +5 | K142350 | PK J-Hook | Gyrus Acmi, Inc. | 2015 | 1 | 1 |
| +5 | K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | 2014 | 0 | — |
| +5 | K130606 | Fmwand Ferromagnetic Surgical System | Domain Surgical, Inc. | 2014 | 3 | — |
| +5 | K131205 | Arthrocare Head and Neck Coblation Wand | ArthroCare Corporation | 2013 | 0 | — |
| +5 | K130305 | Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size | Lina Medical Aps | 2013 | 0 | — |
| +5 | K122605 | PKS Bill | Gyrus Acmi, Inc. | 2012 | 1 | — |
| +5 | K102366 | Finess Endoscope | Entellus Medical, Inc. | 2011 | 0 | — |
| +5 | K100896 | Gyrus Acmi Halo PKS Cutting Forceps | Gyrus Acmi, Inc. | 2010 | 3 | 1 |
| +5 | K081766 | PKS Omni Instrument | Gyrus-Acmi L.P. | 2008 | 3 | 1 |
| +5 | K081954 | Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable | Gyrus Acmi, Inc. | 2008 | 0 | — |
| +5 | K071759 | LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand… | Live Tissue Connect, Inc. | 2008 | 0 | — |
| +5 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | 42 | — |
| +5 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control… | Arthrocare Corp. | 2006 | 40 | — |
| +5 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | 0 | — |
| +6 | K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026 | 0 | — |
| +6 | K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35… | Olympus Medical Systems Corp. | 2026 | 0 | — |
| +6 | K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026 | 0 | — |
| +6 | K250852 | Coolfase | Asterasys Co., Ltd. | 2025 | 0 | — |
| +6 | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)… | Olympus Medical Systems Corporation | 2025 | 0 | 4 |
| +6 | K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | 2025 | 0 | — |
| +6 | K251327 | XERF | Lutronic Corporation | 2025 | 0 | 1 |
| +6 | K240857 | Youmagic FLM System (YM5-U1) | We Medical Technology (Wuxi) Co., Ltd. | 2025 | 0 | — |
| +6 | K242241 | Sunny | ShenB Co., Ltd. | 2025 | 0 | — |
| +6 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System… | Boston Aesthetics, Inc. | 2025 | 1 | — |
| +6 | K233118 | DUET-V (Model: ESK-3261DV) | Eunsung Global Corp | 2025 | 0 | — |
| +6 | K242688 | Finiff System | Skingrab Co., Ltd. | 2024 | 0 | — |
| +6 | K242553 | MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. | 2024 | 0 | — |
| +6 | K240248 | Volnewmer™ | Classys, Inc. | 2024 | 1 | — |
| +6 | K232992 | 10THERMA | Tentech, Inc. | 2023 | 0 | — |
| +6 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories… | Olympus Winter & Ibe GmbH | 2023 | 0 | 2 |
| +6 | K230663 | Density | Jeisys Medical, Inc. | 2023 | 2 | — |
| +6 | K221989 | The Oligio | Wontech Co., Ltd. | 2022 | 2 | — |
| +6 | K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2022 | 1 | — |
| +6 | K212891 | TempSure System | Cynosure, LLC | 2022 | 1 | — |
| +6 | K211639 | BTL-785W | BTL Industries, Inc. | 2022 | 7 | — |
| +6 | K220071 | Soniquence Reusable Neutral Plate | Soniquence, LLC | 2022 | 0 | — |
| +6 | K210129 | RF Thermal System | Luvo Medical Technologies, Inc. | 2021 | 1 | — |
| +6 | K202562 | Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips… | Ellusa, LLC | 2020 | 1 | — |
| +6 | K200427 | Sonicision Cordless Ultrasonic Dissector | Covidien, LLC | 2020 | 0 | — |
| +6 | K191583 | PhotonBlade with Smoke Evacuation | Invuity, Inc. | 2020 | 0 | — |
| +6 | K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service and Savings, Inc. | 2018 | 0 | — |
| +6 | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw… | Covidien, LLC | 2018 | 1 | 2 |
| +6 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | 2 | — |
| +6 | K142759 | PK Cutting Forceps for ESG-400 Workstation | Gyrus Acmi, Inc. | 2015 | 2 | — |
| +6 | K141484 | Open Fmsealer | Domain Surgical, Inc. | 2014 | 1 | 1 |
| +6 | K140384 | Fmwand Handpiece SE | Domain Surgical, Inc. | 2014 | 0 | — |
| +6 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | 36 | — |
| +6 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | 41 | — |
| +7 | K253504 | Volnewmer™ | Classys, Inc. | 2026 | 0 | — |
| +7 | K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group | 2026 | 0 | — |
| +7 | K251988 | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | 2026 | 0 | — |
| +7 | K250065 | DENSITY; DENZA; DENSITY Noir | Jeisys Medical Incorporated | 2025 | 0 | — |
| +7 | K240897 | Cellinew | VIOL Co., Ltd. | 2024 | 0 | — |
| +7 | K240313 | Oligio X | Wontech Co., Ltd. | 2024 | 1 | — |
| +7 | K222556 | BTL-785X | BTL Industries, Inc. | 2023 | 5 | — |
| +7 | K223292 | TempSure System | Cynosure, LLC | 2022 | 0 | — |
| +7 | K222425 | Ellusa Reusable Neutral Plates | Ellusa, LLC | 2022 | 0 | — |
| +7 | K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | Covidien, LLC | 2021 | 0 | — |
| +7 | K212607 | Darwin | Luvo Medical Technologies, Inc. | 2021 | 0 | — |
| +7 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Olympus Winter & Ibe GmbH | 2021 | 1 | 4 |
| +7 | K181838 | Sinusway Dilation System | 3nt Medical, Ltd. | 2018 | 0 | — |
| +7 | K163373 | PK AIM | Gyrus Acmi, Inc. | 2016 | 1 | — |
| +7 | K142229 | Laparoscopic FMsealer | Domain Surgical, Inc. | 2015 | 0 | — |
| +7 | K132297 | EM Sinus Dilation System | Medtronic Xomed, Inc. | 2013 | 5 | — |
| +7 | K120280 | Relieva Seeker Balloon Sinuplasty System | Acclarent, Inc. | 2012 | 2 | — |
| +7 | K121351 | Sinus Dilation System | Entrigue Surgical, Inc. | 2012 | 8 | — |
| +7 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | 21 | — |
| +7 | K111875 | Relieva Spin Sinus Dilation System | Acclarent, Inc. | 2011 | 7 | — |
| +7 | K111254 | Relieva Solo Elite Sinus Balloon Catheter | Acclarent, Inc. | 2011 | 7 | — |
| +7 | K110158 | Illuminating Sinus Seeker | Entellus Medical, Inc. | 2011 | 3 | — |
| +8 | K243929 | Oligio X | Wontech Co., Ltd. | 2025 | 0 | — |
| +8 | K233849 | BTL-499 | BTL Industries, Inc. | 2024 | 0 | — |
| +8 | K233604 | BTL-785S | BTL Industries, Inc. | 2024 | 3 | — |
| +8 | K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020 | 1 | — |
| +8 | K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019 | 0 | — |
| +8 | K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | 2017 | 0 | — |
| +8 | K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016 | 1 | — |
| +8 | K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016 | 0 | — |
| +8 | K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015 | 0 | — |
| +8 | K143738 | DSS Sinusplasty Balloon Catheter | Intuit Medical Products, LLC | 2015 | 0 | — |
| +8 | K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | 2015 | 2 | — |
| +8 | K140160 | Relieva Scout Sinus Dilation System | Acclarent, Inc. | 2014 | 0 | — |
| +8 | K133016 | Vent-OS Sinus Dilation System | Sinusys Corporation | 2013 | 0 | — |
| +8 | K131709 | Sinus Dilation System with Cannulated Instrument | Arthrocare Corp. | 2013 | 0 | — |
| +8 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | 20 | — |
| +8 | K113522 | Pathassist Light Seeker | Entellus Medical, Inc. | 2012 | 2 | — |
| +9 | K253750 | BTL-785NEH | BTL Industries, Inc. | 2026 | 0 | — |
| +9 | K242532 | BTL-785BNF-E | BTL Industries, Inc. | 2024 | 1 | — |