Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 35
- Latest Decision
- 2018-05-18
Clearances · page 32 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K180908 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | GEI | Class II | 2018-05-18 |
| K180217 | VESTEX Apparel | Vestagen Protective Technologies, Inc. | QBW | Class II | 2018-05-18 |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | ESW | Class II | 2018-05-18 |
| K180445 | reVive Light Therapy LED Ultrasonic Wrinkle System | Led Technologies, Inc. | OHS | Class II | 2018-05-15 |
| K181153 | ICEfx Cryoablation System | Galil Medical, Inc. | GEH | Class II | 2018-05-15 |
| K180383 | Light based hair removal device | Shenzhen Gsd Tech Co., Ltd. | OHT | Class II | 2018-05-11 |
| K180625 | Rondek PGA Suture (Beige or Violet) | Rk Manufacturing Corporation | GAM | Class II | 2018-05-10 |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad | Medela AG | OMP | Class II | 2018-05-09 |
| K180922 | Empower H100, Cyber Ho 100, Litho 100 | Quanta System Spa | GEX | Class II | 2018-05-08 |
| DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | QAU | Class II | 2018-05-07 |
| K180031 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | GEI | Class II | 2018-05-07 |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | Origami Surgical, LLC | GAM | Class II | 2018-05-04 |
| K180623 | Ulthera System | Ulthera, Inc. | OHV | Class II | 2018-05-04 |
| K180162 | VivaScope System | Caliber Imaging & Diagnostics, Inc. | PSN | Class II | 2018-05-03 |
| K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | ArthroCare Corporation | GEI | Class II | 2018-05-01 |
| K172555 | SAPPHIRE, ELEVARE SAPPHIRE | Omm Imports, Inc. D/B/A Zero Gravity | OLP | Class II | 2018-05-01 |
| K173304 | Finessis Intense Polyisoprene Surgical Glove | Lucenxia Prescience AG | KGO | Class I | 2018-04-30 |
| K172636 | VitaMESH Macroporous PP Surgical Mesh | Proxy Biomedical , Ltd. | FTL | Class II | 2018-04-30 |
| K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | Olympus Winter & Ibe GmbH | GEI | Class II | 2018-04-26 |
| K173143 | Phasix ST Mesh | C.R. Bard, Inc. | OWT | Class II | 2018-04-25 |
| K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | FTL | Class II | 2018-04-24 |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | Stryker Sustainability Solutions | NUJ | Class II | 2018-04-23 |
| K171443 | Etherea MX | Vydence Medical Industria E Comercio Ltda | GEX | Class II | 2018-04-20 |
| K180618 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | OMP | Class II | 2018-04-20 |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | Pt. Medisafe Technologies | KGO | Class I | 2018-04-20 |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | NUJ | Class II | 2018-04-20 |
| K180140 | ProFlex Laser Fibers | Innovaquartz, LLC | GEX | Class II | 2018-04-20 |
| K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) | Lpi, Inc. | LEJ | Class II | 2018-04-19 |
| K172610 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S | Olympus Medical Systems Corp. | GEI | Class II | 2018-04-17 |
| K180353 | Diode laser hair removal device | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2018-04-17 |
| K180699 | Voyant Open Fusion Device | Applied Medical Resources Corporation | GEI | Class II | 2018-04-13 |
| K173889 | Medline Cautery Electrode (PTFE) | Medline Industries, Inc. | GEI | Class II | 2018-04-09 |
| K180372 | Aurora Evacuator | Rebound Therapeutics | GEI | Class II | 2018-04-09 |
| K173386 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs | Lucenxia Prescience AG | KGO | Class I | 2018-04-09 |
| K180630 | PTFE SURGICAL SUTURE | Omnia Spa | NBY | Class II | 2018-04-06 |
| K180614 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | OMP | Class II | 2018-04-06 |
| K180584 | Viveve RF System, Secure | Viveve, Inc. | GEI | Class II | 2018-04-06 |
| K172368 | Bipolar Micro-Coagulation Forceps | Gunter Bissinger Medizintechnik GmbH | GEI | Class II | 2018-04-05 |
| K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | OXF | Class II | 2018-04-05 |
| K172963 | Master-Frank N95 Particulate Respirator | Master & Frank Enterprise Co., Ltd. | MSH | Class II | 2018-04-04 |
| K180320 | dpl IIa Panel | Led Technologies, Inc. | OHS | Class II | 2018-04-03 |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Lumenis, Ltd. | GEX | Class II | 2018-04-03 |
| K180531 | NovoStitch Pro Meniscal Repair System | Ceterix Orthopaedics, Inc. | GAT | Class II | 2018-03-29 |
| K173214 | NES Reprocessed RF Stylet (RFS) | Northeast Scientific, Inc. (Nes) | NUJ | Class II | 2018-03-27 |
| K173922 | C-PTFETM Surgical Suture | Cp Medical, Inc. | NBY | Class II | 2018-03-26 |
| K180443 | Tumark Vision | Somatex Medical Technologies GmbH | NEU | Class II | 2018-03-22 |
| K180211 | Freezpoint | Bovie Medical Corp. | GEH | Class II | 2018-03-21 |
| K170957 | ReConnex Pre-Sutured Tendon | Allosource | GAT | Class II | 2018-03-20 |
| K180016 | Home Use IPL Beauty Device | Shenzhen Mismon Technology Co., Ltd. | OHT | Class II | 2018-03-20 |
| K173740 | Reprocessed DePuy Mitek Ablation Wand | Renovo, Inc. | NUJ | Class II | 2018-03-19 |
| K180426 | Empower H35 | Quanta System Spa | GEX | Class II | 2018-03-16 |
| K180406 | Ellipse Ydun | Ellipse A/S | GEX | Class II | 2018-03-15 |
| K180396 | miraDry System | Miramar Labs, Inc. | NEY | Class II | 2018-03-15 |
| K180224 | ELEMENT-TL | Elemenic Co., Ltd. | GEX | Class II | 2018-03-15 |
| K180423 | Empower H65 | Quanta System Spa | GEX | Class II | 2018-03-15 |
| K172012 | star RF Electrode, VIVA RF Electrode | Starmed Co., Ltd. | GEI | Class II | 2018-03-14 |
| K171817 | Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated | FTM | Class II | 2018-03-13 |
| K173779 | REXMONO, PDREX | Sm Eng Co., Ltd. | GAM | Class II | 2018-03-12 |
| K180061 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | NEU | Class II | 2018-03-09 |
| K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) | Sofradim Production | FTL | Class II | 2018-03-09 |
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | Kci USA, Inc. | OMP | Class II | 2018-03-09 |
| K173323 | AnastoClip GC Closure System | LeMaitre Vascular, Inc. | FZP | Class II | 2018-03-08 |
| K180044 | SIROLaser Blue | Dentsply Sirona | GEX | Class II | 2018-03-08 |
| K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | GAW | Class II | 2018-03-07 |
| K172818 | LMT-3000 | Lameditech Co. , Ltd. | GEX | Class II | 2018-03-07 |
| K180350 | Dornier Medilas H Solvo 35 Laser | Dornier Medtech America | GEX | Class II | 2018-03-07 |
| K173741 | Reprocessed ArthoCare Ablation Wand | Renovo, Inc. | NUJ | Class II | 2018-03-05 |
| K173447 | V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit | Kci USA, Inc. | OMP | Class II | 2018-03-02 |
| K173281 | LigaSure Exact Dissector, Nano-coated | Covidien | GEI | Class II | 2018-03-02 |
| K162366 | Omega VL | Ov World Co., Ltd. | NEW | Class II | 2018-03-02 |
| K172500 | Technoweb Surgical Mask | Yts Global, Inc. | FXX | Class II | 2018-03-01 |
| DEN160029 | SkinPen Precision System | Bellus Medical, LLC | QAI | Class II | 2018-03-01 |
| K171869 | Sutter CURIS RF Generator | Sutter Medizintechnik GmbH | GEI | Class II | 2018-02-23 |
| K173677 | InMode VLaze | Inmode MD , Ltd. | GEX | Class II | 2018-02-23 |
| K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000 | Litecure, LLC | GEX | Class II | 2018-02-22 |
| K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) | El.En Electronic Engineering Spa | GEX | Class II | 2018-02-21 |
| K172647 | Reprocessed ArthroCare ENT Coblator | Renovo, Inc. | NUJ | Class II | 2018-02-21 |
| K173270 | Tri-Staple 2.0 Reinforced Reload | Covidien | GDW | Class II | 2018-02-20 |
| K173587 | Magseed Magnetic Marker Systtem | Endomagnetics Ltd., | NEU | Class II | 2018-02-16 |
| K172361 | EEA Circular Stapler with Tri-Staple Technology | Covidien | GDW | Class II | 2018-02-16 |
| K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | GEI | Class II | 2018-02-15 |
| K173644 | Gazelle Polypropylene Suture and Delivery Device | Dura Tap, LLC | GAW | Class II | 2018-02-15 |
| K171535 | SURGICAL ISOLATION GOWN | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | FYC | Class II | 2018-02-15 |
| K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) | AtriCure, Inc. | GEH | Class II | 2018-02-15 |
| K180158 | Surgical Laser fibers | Quanta System Spa | GEX | Class II | 2018-02-14 |
| K172439 | Siberian Fit | Vydence | GEX | Class II | 2018-02-14 |
| K173565 | Sunrise 6200, Sunrise 7200 | Jk-Holding GmbH | LEJ | Class II | 2018-02-14 |
| K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | GEI | Class II | 2018-02-13 |
| K172624 | Voyant 5mm Fusion Device | Applied Medical Resources Corporation | GEI | Class II | 2018-02-13 |
| K172883 | Home Use Hair Removal Device/T1, T2, T3 | Shenzhen Mareal Tech Co., Ltd. | OHT | Class II | 2018-02-12 |
| K173335 | Gazelle PTFE and Suture Delivery Device | Dura Tap, LLC | NBY | Class II | 2018-02-08 |
| K173199 | PicoSure Workstation | Cynosure, Inc. | GEX | Class II | 2018-02-07 |
| K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | Ansell Healthcare Products, LLC | KGO | Class I | 2018-02-06 |
| K172005 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | OMP | Class II | 2018-02-02 |
| K180036 | SMAXEL CO2 Surgical Laser System | Ids, Ltd. | ONG | Class II | 2018-02-02 |
| K173443 | AEON Endoscopic Stapler | Lexington Medical, Inc. | GDW | Class II | 2018-02-01 |
| K172395 | Duatene bilayer mesh | Sofradim Production | FTL | Class II | 2018-02-01 |
| K172146 | MERISTEEL | M/s. Meril Endo Surgery Private Limited. | GAQ | Class II | 2018-02-01 |
| K180010 | AtriClip FLEX-V | AtriCure, Inc. | FZP | Class II | 2018-01-31 |
| K173389 | Rex Medical Aspiration Pump | Rex Medical, L.P. | BTA | Class II | 2018-01-30 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.