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 6 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments | Carefusion 2200, Inc. | 2017-05-04 | Traditional | PDF ↗ |
| K170107 | Surgi Max Ultra | Elliquence, LLC | 2017-05-03 | Traditional | PDF ↗ |
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | Bovie Medical Corporation | 2017-05-01 | Traditional | PDF ↗ |
| K170358 | joimax Endovapor 2 | Joimax GmbH | 2017-04-21 | Traditional | PDF ↗ |
| K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2017-04-21 | Special | PDF ↗ |
| K170721 | Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil | Precision Surgical, LLC | 2017-04-21 | Traditional | PDF ↗ |
| K163415 | SlimShape System | Syneron Medical, Ltd. | 2017-04-20 | Traditional | PDF ↗ |
| K170582 | Saf-T-Vac Smoke and Fluid Evacuator | Surgical Technology Laboratories, Inc. | 2017-04-14 | Traditional | PDF ↗ |
| K170610 | PlasmaBlade T | Medtronic Advanced Energy | 2017-04-13 | Traditional | PDF ↗ |
| K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM | Richard Wolf Medical Instruments Corporation | 2017-04-05 | Traditional | PDF ↗ |
| K170161 | New Deantronics E Green Electrosurgical Monopolar Pencils | New Deantronics Taiwan , Ltd. | 2017-03-29 | Traditional | PDF ↗ |
| K170296 | CoreCath 2.7S | Medtronic Advanced Energy | 2017-03-20 | Traditional | PDF ↗ |
| K170116 | Thermi Injectable RF Electrodes | Thermi | 2017-03-13 | Traditional | PDF ↗ |
| K163450 | VIVA combo RF System | Starmed Co., Ltd. | 2017-03-08 | Traditional | PDF ↗ |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator | Bovie Medical Corporation | 2017-03-08 | Traditional | PDF ↗ |
| K170105 | Jac-Cell Medic testers | Jac-Cell Medic | 2017-02-28 | Traditional | PDF ↗ |
| K170170 | Valleylab FT10 Electrosurgical Platform | Covidien, LLC | 2017-02-16 | Special | PDF ↗ |
| K163548 | ENSEAL X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC | 2017-02-14 | Traditional | PDF ↗ |
| K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017-01-31 | Traditional | PDF ↗ |
| K162034 | OBS Electrosurgical Generator (Model: OBS-350A) | Baisheng Medical Co., Ltd. | 2017-01-30 | Traditional | PDF ↗ |
| K162802 | Barrx Anorectal RFA Wand | Covidien, LLC | 2017-01-24 | Traditional | PDF ↗ |
| K162810 | InSeca ARC Stylus, Aerin Console | Aerin Medical, Inc. | 2017-01-11 | Traditional | PDF ↗ |
| K162490 | Disc-FX System | Elliquence, LLC | 2017-01-06 | Traditional | PDF ↗ |
| K160469 | AGNES | Gowoonsesang Cosmetics Co., Ltd. | 2017-01-05 | Traditional | PDF ↗ |
| K162770 | Relign System | Relign Corporation | 2017-01-04 | Traditional | PDF ↗ |
| K161307 | NICO Myriad | Nico Corporation | 2016-12-21 | Traditional | PDF ↗ |
| K163190 | InMode RF System | Inmode MD , Ltd. | 2016-12-12 | Special | PDF ↗ |
| K163373 | PK AIM | Gyrus Acmi, Inc. | 2016-12-12 | Special | PDF ↗ |
| K162676 | Voyant Open Fusion Device | Applied Medical Resources | 2016-12-01 | Traditional | PDF ↗ |
| K163106 | CODMAN Integrated Bipolar Cord and Tubing Set | Medos International SARL | 2016-12-01 | Special | PDF ↗ |
| K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | Covidien | 2016-11-14 | Special | PDF ↗ |
| K162656 | ESU-1 Electrosurgical Generator | Tva Medical, Inc. | 2016-11-10 | Traditional | PDF ↗ |
| K161378 | joimax Electrosurgical Instruments | Joimax GmbH | 2016-11-02 | Traditional | PDF ↗ |
| K162469 | CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps | Medos International SARL | 2016-10-26 | Traditional | PDF ↗ |
| K161481 | Ambient HipVac 50 Wand with Integrated Finger Switches | ArthroCare Corporation | 2016-10-21 | Traditional | PDF ↗ |
| K160706 | ReNew V Handpiece Laparoscopic Instruments | Microline Surgical, Inc. | 2016-10-19 | Traditional | PDF ↗ |
| K160103 | Spetzler Malis Dual Illuminating Bipolar Forceps | Synergetics | 2016-10-12 | Traditional | PDF ↗ |
| K161038 | PK Morcellator | Gyrus Acmi, Inc. | 2016-10-07 | Traditional | PDF ↗ |
| K162547 | Viveve System | Viveve, Inc. | 2016-10-06 | Special | PDF ↗ |
| K162126 | Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) | ArthroCare Corporation | 2016-09-29 | Traditional | PDF ↗ |
| K161825 | PK AIM | Gyrus Acmi, Inc. | 2016-09-26 | Traditional | PDF ↗ |
| K161994 | Aerin Medical Stylus | Aerin Medical, Inc. | 2016-09-22 | Special | PDF ↗ |
| K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | Covidien | 2016-09-16 | Traditional | PDF ↗ |
| K162053 | PhotonBlade | Invuity, Inc. | 2016-09-15 | Traditional | PDF ↗ |
| K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | Covidien | 2016-09-15 | Special | PDF ↗ |
| K160554 | Enseal X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC | 2016-09-09 | Traditional | PDF ↗ |
| K161581 | Arthrex Synergy RF System | Arthrex, Inc. | 2016-09-09 | Traditional | PDF ↗ |
| K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | Venclose, Inc. | 2016-09-09 | Traditional | PDF ↗ |
| K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | ArthroCare Corporation | 2016-08-22 | Special | PDF ↗ |
| K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp | Covidien | 2016-08-12 | Traditional | PDF ↗ |
| K161661 | Thermi RF Accessories | Thermi | 2016-08-12 | Traditional | PDF ↗ |
| K162075 | NICO TRIOwand | Nico Corporation | 2016-08-11 | Special | PDF ↗ |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating | Bovie Medical Corporation | 2016-07-29 | Traditional | PDF ↗ |
| K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System | Jeisys Medical, Inc. | 2016-07-21 | Traditional | PDF ↗ |
| K152731 | XP1100 RF | BTL Industries, Inc. | 2016-07-20 | Traditional | PDF ↗ |
| K153055 | ACE Electrosurgical Resection and Vaporization Electrodes Series | Ace Medical Devices Pvt. , Ltd. | 2016-07-11 | Traditional | PDF ↗ |
| K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | Medtronic Advanced Energy | 2016-07-08 | Traditional | PDF ↗ |
| K161305 | Habib EUS RFA | Emcision , Ltd. | 2016-07-07 | Traditional | PDF ↗ |
| K153017 | Voyant Fine Fusion | Applied Medical Resources | 2016-07-06 | Traditional | PDF ↗ |
| K160602 | JustRight Surgical Vessel Sealing System | Justright Surgical | 2016-06-23 | Traditional | PDF ↗ |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator | Bovie Medical Corporation | 2016-06-20 | Traditional | PDF ↗ |
| K160539 | BiZact Open Sealer/Divider | Covidien | 2016-06-15 | Traditional | PDF ↗ |
| K151229 | ABC D-FLEX PROBE | Conmed Corporation | 2016-06-02 | Traditional | PDF ↗ |
| K153288 | Voyant Open Fusion Device | Applied Medical Resources | 2016-06-01 | Traditional | PDF ↗ |
| K160290 | Valleylab REM Polyhesive Infant Patient Return Electrode | Covidien, LLC | 2016-05-19 | Traditional | PDF ↗ |
| K160053 | Monopolar single-use HF cable | Olympus Winter & Ibe GmbH | 2016-05-06 | Traditional | PDF ↗ |
| K150364 | ERBE ESU Model VIO dV with Accessories | Erbe Elektromedizin GmbH | 2016-05-05 | Traditional | PDF ↗ |
| K160639 | Electrosurgical Generator ESG-200 | Olympus Winter & Ibe GmbH | 2016-05-04 | Traditional | PDF ↗ |
| K160050 | SERFAS 90-S Electrosurgical Probe | Stryker Corporation | 2016-05-03 | Traditional | PDF ↗ |
| K160128 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | 2016-04-28 | Traditional | PDF ↗ |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corporation | 2016-04-21 | Traditional | PDF ↗ |
| K152059 | Disposable General Electrode | Modern Medical Equipment Manufacturing Limited | 2016-04-21 | Traditional | PDF ↗ |
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting System | Maquet Cardiovascular, LLC | 2016-04-19 | Traditional | PDF ↗ |
| K160693 | Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016-04-13 | Special | PDF ↗ |
| K153063 | PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM | Teleflexmedical, Inc. | 2016-04-08 | Traditional | PDF ↗ |
| K160360 | Barrx FLEX RFA Energy Generator | Covidien, LLC | 2016-04-05 | Traditional | PDF ↗ |
| K160160 | Non-Telescopic PenEvac | I.C Medical, Inc. | 2016-04-05 | Special | PDF ↗ |
| K152933 | Vesalius | Telea Electronic Engineering Srl | 2016-03-23 | Special | PDF ↗ |
| K150915 | SPINAUT-P | Imedicom Co., Ltd. | 2016-03-18 | Traditional | PDF ↗ |
| K160041 | Cobbra RF Tissue Dissector | Elliquence, LLC | 2016-03-07 | Traditional | PDF ↗ |
| K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016-02-26 | Traditional | PDF ↗ |
| K151480 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources | 2016-02-19 | Traditional | PDF ↗ |
| K151793 | InMode RF System | Inmode MD , Ltd. | 2016-02-19 | Traditional | PDF ↗ |
| K152702 | ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) | Ent Biotech Solutions | 2016-02-18 | Traditional | PDF ↗ |
| K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016-01-22 | Special | PDF ↗ |
| K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016-01-15 | Traditional | PDF ↗ |
| K153675 | Paragon T2 Wand with Integrated Cable | ArthroCare Corporation | 2016-01-15 | Special | PDF ↗ |
| K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated | New Deantronics Taiwan , Ltd. | 2016-01-05 | Traditional | PDF ↗ |
| K151273 | InMode FRF Applicator | Inmode MD , Ltd. | 2016-01-04 | Traditional | PDF ↗ |
| K152860 | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL | Conmed Corporation | 2015-12-29 | Traditional | PDF ↗ |
| K153499 | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension | Conmed Corporation | 2015-12-18 | Special | PDF ↗ |
| K152219 | PK AIM | Gyrus Acmi, Inc. | 2015-12-17 | Traditional | PDF ↗ |
| K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2015-11-24 | Traditional | PDF ↗ |
| K150637 | Aerin Medical Wand Model FG011 | Aerin Medical, Inc. | 2015-11-19 | Traditional | PDF ↗ |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | Bovie Medical Corporation | 2015-11-02 | Traditional | PDF ↗ |
| K142410 | Elliquence Electrodes | Elliquence, LLC | 2015-10-30 | Traditional | PDF ↗ |
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015-10-27 | Traditional | PDF ↗ |
| K143235 | RF20000a Controller, FLOW 50 Wand | ArthroCare Corporation | 2015-10-23 | Traditional | PDF ↗ |
| K150835 | LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip | Covidien | 2015-10-15 | Traditional | PDF ↗ |
| K151044 | CLICKLINE Scissor Insert for Single Use | Karl Storz Endoscopy America, Inc. | 2015-10-09 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.