FDA Product Code
FDA Product Code GEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 2,319 records · page 5 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183112 | DiLumen Endolumenal Interventional Knife (DiLumen IK) | Lumendi, LLC | 2019-08-02 | Traditional | PDF ↗ |
| K191484 | Renuvion/J-Plasma Precise Handpiece | Apyx Medical Corporation(Formerly Bovie Medical Corporation) | 2019-07-30 | Traditional | PDF ↗ |
| K190678 | TempSure | Cynosure, Inc. | 2019-07-24 | Traditional | PDF ↗ |
| K191601 | Valleylab FT10 Electrosurgical Platform | Covidien | 2019-07-12 | Special | PDF ↗ |
| K190052 | Radio Frequency Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019-06-25 | Traditional | PDF ↗ |
| K190336 | Soniquence Bipolar Electrodes | Soniquence, LLC | 2019-06-20 | Traditional | PDF ↗ |
| K183564 | Electrosurgical Generator | Fulwell, LLC | 2019-06-13 | Traditional | PDF ↗ |
| K190422 | Viveve System 2.0 | Viveve Medical | 2019-06-12 | Traditional | PDF ↗ |
| K191064 | Argon Handset | New Deantronics Taiwan , Ltd. | 2019-06-12 | Traditional | PDF ↗ |
| K183611 | Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC | 2019-05-22 | Traditional | PDF ↗ |
| K190823 | Erbe ESU Model VIO 3 with Accessories | Erbe Elektromedizin GmbH | 2019-05-22 | Traditional | PDF ↗ |
| K183126 | Electrosurgical accessory | New Deantronics Taiwan , Ltd. | 2019-05-08 | Traditional | PDF ↗ |
| K190643 | Medline Electrocautery Pencil | Medline Industries, Inc. | 2019-05-06 | Traditional | PDF ↗ |
| K183526 | Codman Electrosurgical Generator, Foot Pedal | Kls Martin GmbH + Co. KG | 2019-04-11 | Traditional | PDF ↗ |
| K183445 | Erbe APCapplicators | Erbe Elektromedizin GmbH | 2019-04-04 | Traditional | PDF ↗ |
| K190168 | Aquas Probes | Genicon, Inc. | 2019-03-14 | Special | PDF ↗ |
| K183180 | Caiman 5 Maryland | Aesculap, Inc. | 2019-03-12 | Traditional | PDF ↗ |
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces | Bovie Medical Corporation | 2019-03-12 | Traditional | PDF ↗ |
| K182013 | EasyInstruments | Agency For Medical Innovations GmbH | 2019-03-11 | Traditional | PDF ↗ |
| K183240 | Empower RF Catheter | Broncus Medical, Inc. | 2019-02-22 | Traditional | PDF ↗ |
| K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J | New Deantronics Taiwan , Ltd. | 2019-02-19 | Traditional | PDF ↗ |
| K190075 | Aurora Evacuator | Rebound Therapeutics | 2019-02-12 | Special | PDF ↗ |
| K183346 | FLOW 90 Wand | ArthroCare Corporation | 2019-01-24 | Traditional | PDF ↗ |
| K183538 | VIVA combo RF System | Starmed Co., Ltd. | 2019-01-17 | Special | PDF ↗ |
| K181071 | SIRA RFA Electrosurgical Device | Innoblative Designs, Inc. | 2019-01-16 | Traditional | PDF ↗ |
| K182497 | OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2019-01-15 | Traditional | PDF ↗ |
| K182354 | SafeAir Telescopic Smoke Pencil | Lina Medical Aps | 2018-12-14 | Traditional | PDF ↗ |
| K180359 | BTL-FR2000 | BTL Industries, Inc. | 2018-12-13 | Traditional | PDF ↗ |
| K182812 | Medline Cautery Electrode (SILICONE) | Medline Industries, Inc. | 2018-12-12 | Traditional | PDF ↗ |
| K180999 | Mygen V-1000 RF System | RF Medical Co., Ltd. | 2018-12-11 | Traditional | PDF ↗ |
| K180945 | LUTRONIC GENIUS Radiofrequency System | Lutronic Corporation | 2018-12-10 | Traditional | PDF ↗ |
| K182587 | Device Electrosurgical Generator ESG-150 | Olympus Winter & Ibe GmbH | 2018-11-29 | Traditional | PDF ↗ |
| K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable | Integra LifeSciences Corporation | 2018-11-27 | Traditional | PDF ↗ |
| K183009 | HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES | Hemostatix Medical Technologies, LLC | 2018-11-26 | Special | PDF ↗ |
| K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil | Covidien | 2018-11-19 | Traditional | PDF ↗ |
| K182653 | Voyant Maryland Fusion Device | Applied Medical Resources Corp. | 2018-11-14 | Special | PDF ↗ |
| K182451 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC | 2018-11-06 | Traditional | PDF ↗ |
| K182365 | TempSure System | Cynosure, Inc. | 2018-10-24 | Traditional | PDF ↗ |
| K181852 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2018-10-12 | Traditional | PDF ↗ |
| K180872 | SCARLET SRF | VIOL Co., Ltd. | 2018-10-11 | Traditional | PDF ↗ |
| K182244 | Voyant Electrosurgical Generator | Applied Medical Resources Corp. | 2018-10-11 | Special | PDF ↗ |
| K182325 | InMode RF System | Inmode MD , Ltd. | 2018-09-26 | Special | PDF ↗ |
| K182340 | NICO Myriad | Nico Corporation | 2018-09-20 | Special | PDF ↗ |
| K181249 | EUSRA RF Electrode | Starmed Co., Ltd. | 2018-09-04 | Traditional | PDF ↗ |
| K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | Medtronic Advanced Energy | 2018-08-02 | Traditional | PDF ↗ |
| K170369 | Disposable Electrosurgical Pencils | Cathay Manfacturing Corp. | 2018-07-19 | Traditional | PDF ↗ |
| K180654 | PINXEL-RF system | Rohrer Aesthetics, LLC | 2018-07-13 | Traditional | PDF ↗ |
| K180575 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X | Olympus Medical Systems Corp. | 2018-07-12 | Traditional | PDF ↗ |
| K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2018-06-21 | Traditional | PDF ↗ |
| K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | Covidien | 2018-06-19 | Special | PDF ↗ |
| K173503 | Pollogen Legend System | Pollogen, Ltd. | 2018-06-11 | Traditional | PDF ↗ |
| K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD , Ltd. | 2018-06-01 | Traditional | PDF ↗ |
| K180403 | ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length | Ethicon Endo-Surgery, LLC | 2018-05-23 | Traditional | PDF ↗ |
| K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) | Lumendi, LLC | 2018-05-22 | Traditional | PDF ↗ |
| K180908 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2018-05-18 | Traditional | PDF ↗ |
| K180031 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | 2018-05-07 | Traditional | PDF ↗ |
| K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | ArthroCare Corporation | 2018-05-01 | Special | PDF ↗ |
| K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | Olympus Winter & Ibe GmbH | 2018-04-26 | Traditional | PDF ↗ |
| 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. | 2018-04-17 | Traditional | PDF ↗ |
| K180699 | Voyant Open Fusion Device | Applied Medical Resources Corporation | 2018-04-13 | Special | PDF ↗ |
| K180372 | Aurora Evacuator | Rebound Therapeutics | 2018-04-09 | Traditional | PDF ↗ |
| K173889 | Medline Cautery Electrode (PTFE) | Medline Industries, Inc. | 2018-04-09 | Traditional | PDF ↗ |
| K180584 | Viveve RF System, Secure | Viveve, Inc. | 2018-04-06 | Special | PDF ↗ |
| K172368 | Bipolar Micro-Coagulation Forceps | Gunter Bissinger Medizintechnik GmbH | 2018-04-05 | Traditional | PDF ↗ |
| K172012 | star RF Electrode, VIVA RF Electrode | Starmed Co., Ltd. | 2018-03-14 | Traditional | PDF ↗ |
| K173281 | LigaSure Exact Dissector, Nano-coated | Covidien | 2018-03-02 | Traditional | PDF ↗ |
| K171869 | Sutter CURIS RF Generator | Sutter Medizintechnik GmbH | 2018-02-23 | Traditional | PDF ↗ |
| K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | 2018-02-15 | Traditional | PDF ↗ |
| K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2018-02-13 | Traditional | PDF ↗ |
| K172624 | Voyant 5mm Fusion Device | Applied Medical Resources Corporation | 2018-02-13 | Special | PDF ↗ |
| K171391 | Stryker 90-S Max SERFAS Energy Probe | Stryker | 2018-01-26 | Traditional | PDF ↗ |
| K173582 | ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes | Thermigen, L.L.C | 2018-01-17 | Traditional | PDF ↗ |
| K173759 | Thermage CPT System and Accessories | Solta Medical | 2018-01-08 | Special | PDF ↗ |
| K172529 | Vivaer ARC Stylus | Aerin Medical, Inc. | 2017-12-05 | Traditional | PDF ↗ |
| K173112 | LAP-iX | Sejong Medical Co., Ltd. | 2017-11-21 | Traditional | PDF ↗ |
| K172580 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length | Ethicon Endo-Surgery, LLC | 2017-11-20 | Traditional | PDF ↗ |
| K172856 | Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider | Stryker Sustainability Solutions | 2017-11-16 | Traditional | PDF ↗ |
| K172535 | Bipolar applicator CELON ProCurve V | Olympus Winter & Ibe GmbH | 2017-11-16 | Traditional | PDF ↗ |
| K172757 | Valleylab FX8 Electrosurgical Platform | Covidien, LLC | 2017-11-02 | Traditional | PDF ↗ |
| K172805 | gi-4000 Electrosurgical Generator | United States Endoscopy Group, Inc. | 2017-10-23 | Special | PDF ↗ |
| K171752 | X-SURGE | Genicon, Inc. | 2017-10-17 | Special | PDF ↗ |
| K172023 | CELFIRM | VIOL Co., Ltd. | 2017-10-13 | Traditional | PDF ↗ |
| K171593 | InMode RF System | Inmode MD , Ltd. | 2017-10-10 | Traditional | PDF ↗ |
| K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal | Conmed Corporation | 2017-10-04 | Special | PDF ↗ |
| K170054 | iSurg | Jaco, LLC Dba Macan Manufacturing and Bna Burz North America | 2017-10-02 | Abbreviated | PDF ↗ |
| K163442 | Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) | Modern Medical Equipment Manufacturing Limited | 2017-09-28 | Traditional | PDF ↗ |
| K171262 | TempSure | Cynosure, Inc. | 2017-09-22 | Traditional | PDF ↗ |
| K170758 | Thermage FLX System and Accessories | Solta Medical | 2017-09-22 | Traditional | PDF ↗ |
| K171359 | Pollogen Legend+ System | Pollogen, Ltd. | 2017-09-13 | Traditional | PDF ↗ |
| K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini | Medtronic Advanced Energy | 2017-09-07 | Traditional | PDF ↗ |
| K171523 | Monopolar Single Use Laparoscopic Instrument | Getsch+Hiller Medizintechnik GmbH | 2017-08-22 | Traditional | PDF ↗ |
| K172367 | Stryker Integrated Bipolar Cord and Tubing Sets | Stryker Instruments | 2017-08-22 | Special | PDF ↗ |
| K171707 | GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A | Gowoonsesang Cosmetics Co., Ltd. | 2017-08-08 | Traditional | PDF ↗ |
| K171684 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources Corporation | 2017-08-07 | Traditional | PDF ↗ |
| K171717 | AUTOCON III 400 | KARL STORZ Endoscopy-America, Inc. | 2017-08-02 | Traditional | PDF ↗ |
| K170325 | SECRET RF | Ilooda Co,., Ltd. | 2017-06-13 | Traditional | PDF ↗ |
| K171066 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC | 2017-06-08 | Traditional | PDF ↗ |
| K170908 | PK AIM | Gyrus Acmi, Inc. | 2017-05-19 | Traditional | PDF ↗ |
| K170990 | Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator | Spiration, Inc. | 2017-05-11 | Traditional | PDF ↗ |
| K171094 | Thermi Reusable Non-invasive RF Electrode | Thermgen, L.L.C | 2017-05-08 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.