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 7 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K134036 | WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT | Loktal Medical Electronics Ind. Com. Ltda- Epp | 2015-10-08 | Traditional | PDF ↗ |
| K152317 | Stretta Catheter | Mederi Therapeutics, Inc. | 2015-09-23 | Special | PDF ↗ |
| K152031 | New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter. | New Deantronics Taiwan , Ltd. | 2015-09-17 | Traditional | PDF ↗ |
| K150959 | Sutter Bipolar Forceps-Calvian | Sutter Medizintechnik GmbH | 2015-09-10 | Traditional | PDF ↗ |
| K151649 | Valleylab FT10 Electrosurgical Platform | Covidien | 2015-09-10 | Traditional | PDF ↗ |
| K150112 | HS AMICA DEVICES FAMILY | H.S Hospital Service S.P.A | 2015-09-10 | Traditional | PDF ↗ |
| K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | Covidien | 2015-09-08 | Special | PDF ↗ |
| K151325 | Bovie J-Plasma Handpiece | Bovie Medical Corporation | 2015-08-04 | Traditional | PDF ↗ |
| K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot | Covidien | 2015-08-04 | Traditional | PDF ↗ |
| K150251 | Barrx Anorectal RFA Wand | Covidien, LLC | 2015-07-28 | Traditional | PDF ↗ |
| K151858 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2015-07-21 | Special | PDF ↗ |
| K151696 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2015-07-20 | Special | PDF ↗ |
| K143103 | PROPENCIL Smoke Pencil | Bio Protech, Inc. | 2015-07-16 | Traditional | PDF ↗ |
| K150029 | Habib EUS RFA | Emcision , Ltd. | 2015-06-24 | Traditional | PDF ↗ |
| K142480 | OsteoCool V-2 RF Ablation System | Baylis Medical Company, Inc. | 2015-06-16 | Traditional | PDF ↗ |
| K143559 | XP1000 RF | BTL Industries, Inc. | 2015-06-11 | Traditional | PDF ↗ |
| K150824 | TD-Wand | Tdm Surgitech, Inc. | 2015-05-28 | Traditional | PDF ↗ |
| K151222 | Cautery Tip Cleaner | Key Surgical, Inc. | 2015-05-22 | Traditional | PDF ↗ |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | Medtronic Advanced Energy | 2015-05-21 | Traditional | PDF ↗ |
| K150161 | Venus Viva SR Device | Venus Concept , Ltd. | 2015-05-12 | Traditional | PDF ↗ |
| K150993 | NICO TRIOwand | Nico Corporation | 2015-04-23 | Traditional | PDF ↗ |
| K143536 | Voyant Fine Fusion Device | Applied Medical Resources | 2015-04-16 | Traditional | PDF ↗ |
| K142208 | Monopolar Laparascopic Accessories | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015-04-13 | Traditional | PDF ↗ |
| K143654 | Valleylab LS10 Generator | Covidien, LLC | 2015-04-03 | Traditional | PDF ↗ |
| K143475 | VAPR Tripolar Suction Electrode | Depuy Mitek | 2015-04-03 | Traditional | PDF ↗ |
| K143517 | Voyant Open Sealer-Divider Device | Applied Medical Resources | 2015-03-27 | Traditional | PDF ↗ |
| K143662 | Bissinger Monopolar Forceps and Cables | Medagent, Inc. | 2015-03-12 | Traditional | PDF ↗ |
| K143109 | XP300 | BTL Industries, Inc. | 2015-03-06 | Special | PDF ↗ |
| K141790 | AQANIFE | Ovesco Endoscopy AG | 2015-03-06 | Traditional | PDF ↗ |
| K150024 | Bissinger Monopolar Cables | Guenter Bissinger Medizintechnik GmbH | 2015-02-20 | Traditional | PDF ↗ |
| K142248 | Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope | Urologix, Inc. | 2015-02-20 | Traditional | PDF ↗ |
| K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER | Megadyne Medical Products, Inc. | 2015-02-18 | Traditional | PDF ↗ |
| K142929 | Ligasure Blunt Tip Sealer/Divider | Covidien | 2015-01-27 | Traditional | PDF ↗ |
| K142759 | PK Cutting Forceps for ESG-400 Workstation | Gyrus Acmi, Inc. | 2015-01-13 | Traditional | PDF ↗ |
| K142350 | PK J-HOOK | Gyrus Acmi, Inc. | 2015-01-08 | Traditional | PDF ↗ |
| K142229 | Laparoscopic FMsealer | Domain Surgical, Inc. | 2015-01-02 | Traditional | PDF ↗ |
| K142289 | PK Spatula | Gyrus Acmi, Inc. | 2014-12-31 | Traditional | PDF ↗ |
| K143175 | AEx Generator; PlasmaBlade T | Medtronic Advanced Energy | 2014-12-31 | Traditional | PDF ↗ |
| K143161 | Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) | Covidien | 2014-12-19 | Special | PDF ↗ |
| K142910 | Legacy BX | Venus Concept USA, Inc. | 2014-12-19 | Special | PDF ↗ |
| K142154 | PK NEEDLE | Gyrus Acmi, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | Bovie Medical Corporation | 2014-12-12 | Traditional | PDF ↗ |
| K140624 | HICURA HAND INSTRUMENTS | Olympus Winter & Ibe GmbH | 2014-12-10 | Traditional | PDF ↗ |
| K141507 | TWO SKIN TREATMENT SYSTEM | Syneron Medical, Ltd. | 2014-12-08 | Traditional | PDF ↗ |
| K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014-12-04 | Special | PDF ↗ |
| K140926 | INMODE WMFACE DEVICE | Inmode MD , Ltd. | 2014-12-03 | Traditional | PDF ↗ |
| K142868 | 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin | Purple Surgical International Limited | 2014-11-21 | Traditional | PDF ↗ |
| K134006 | DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE | Modern Medical Equipment Manufacturing Limited | 2014-11-21 | Traditional | PDF ↗ |
| K142999 | EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable | ArthroCare Corporation | 2014-11-19 | Special | PDF ↗ |
| K140008 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM | Terumo Cardiovascular Systems Corporation | 2014-10-31 | Traditional | PDF ↗ |
| K132771 | KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS | Qingdao Kingston Medical Devices, Ltd. | 2014-10-28 | Traditional | PDF ↗ |
| K142757 | LiNA PowerBlade Plus HC | Lina Medical Aps | 2014-10-23 | Special | PDF ↗ |
| K141904 | VIORA V-TOUCH | Viora , Ltd. | 2014-10-21 | Traditional | PDF ↗ |
| K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014-10-06 | Special | PDF ↗ |
| K142364 | Barrx RFA Self Sizing Balloon Catheter | Covidien, LLC | 2014-10-01 | Special | PDF ↗ |
| K141122 | HARMONIC SCALLOP BLADE, GENERATOR G11 | Ethicon Endo-Surgery, LLC | 2014-09-15 | Traditional | PDF ↗ |
| K141288 | VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE | Applied Medical Resources | 2014-08-22 | Traditional | PDF ↗ |
| K141357 | BARRX FLEX RFA ENERGY GENERATOR | Covidien Iic | 2014-08-21 | Traditional | PDF ↗ |
| K141153 | LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED | Covidien | 2014-08-14 | Traditional | PDF ↗ |
| K141225 | ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD | Olympus Winter & Ibe GmbH | 2014-08-12 | Traditional | PDF ↗ |
| K140896 | VAPR ARCTIC SUCTION ELECTRODE | Depuy Mitek, A Johnson & Johnson Company | 2014-08-05 | Traditional | PDF ↗ |
| K141858 | CLOSURERFG RADIOFREQUENCY GENERATOR | Covidien | 2014-08-05 | Special | PDF ↗ |
| K140603 | ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM | Saphena Medical, Inc. | 2014-07-31 | Traditional | PDF ↗ |
| K141484 | OPEN FMSEALER | Domain Surgical, Inc. | 2014-07-30 | Traditional | PDF ↗ |
| K132797 | L'DISQ | U&I Corporation | 2014-07-30 | Traditional | PDF ↗ |
| K140500 | SKINTACT | Leonhard Lang GmbH | 2014-07-29 | Traditional | PDF ↗ |
| K140578 | ARTHROSCOPIC ENERGY SYSTEM | Conmed Corporation | 2014-07-23 | Traditional | PDF ↗ |
| K140459 | ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM | Conmed Corporation | 2014-07-11 | Traditional | PDF ↗ |
| K140658 | THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES | Conmed Corporation | 2014-07-10 | Traditional | PDF ↗ |
| K140629 | VENUS SWAN(MP)2 | Venus Concept , Ltd. | 2014-06-25 | Traditional | PDF ↗ |
| K140006 | ENDOSHIELD BURN PROTECTION SYSTEM | Encision, Inc. | 2014-06-16 | Traditional | PDF ↗ |
| K140521 | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH | ArthroCare Corporation | 2014-06-10 | Special | PDF ↗ |
| K140422 | HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM | Het Systems, LLC | 2014-06-05 | Traditional | PDF ↗ |
| K140384 | FMWAND HANDPIECE SE | Domain Surgical, Inc. | 2014-05-23 | Traditional | PDF ↗ |
| K133405 | MINNIE | Elettronica Valseriana Srl | 2014-05-23 | Traditional | PDF ↗ |
| K132703 | THUNDERBEAT | Olympus Medical Systems Corp. | 2014-05-19 | Traditional | PDF ↗ |
| K140255 | STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) | Pollogen, Ltd. | 2014-05-14 | Traditional | PDF ↗ |
| K140839 | CAIMAN SEAL AND CUT TECHNOLOGY | Aesculap, Inc. | 2014-04-28 | Special | PDF ↗ |
| K140495 | LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE | Boston Scientific Corp | 2014-04-17 | Traditional | PDF ↗ |
| K134054 | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Bovie Medical Corporation | 2014-03-17 | Traditional | PDF ↗ |
| K133273 | LIGER MEDICAL ESU-110 | Liger Medical, LLC | 2014-02-12 | Traditional | PDF ↗ |
| K131696 | VESALIUS | Telea Electronic Engineering Srl | 2014-01-31 | Traditional | PDF ↗ |
| K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | Megadyne Medical Products, Inc. | 2014-01-24 | Special | PDF ↗ |
| K132300 | EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE | Applied Medical Resources Corp. | 2014-01-24 | Traditional | PDF ↗ |
| K133167 | MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD | Intuitive Surgical, Inc. | 2014-01-07 | Traditional | PDF ↗ |
| K133338 | LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013-12-20 | Traditional | PDF ↗ |
| K132837 | LINA POWERBLADE PLUS | Lina Medical Aps | 2013-12-19 | Traditional | PDF ↗ |
| K131758 | SURGEN U | Pollogen, Ltd. | 2013-12-18 | Traditional | PDF ↗ |
| K132754 | NEOGEN PSR SYSTEM | Energist, Ltd. | 2013-12-12 | Traditional | PDF ↗ |
| K133180 | ERBE ESU MODEL VIO DV WITH ACCESSORIES | Erbe USA, Inc. | 2013-12-11 | Special | PDF ↗ |
| K130669 | SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS | Olsen Medical | 2013-12-06 | Traditional | PDF ↗ |
| K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR | Medtronic Advanced Energy, LLC | 2013-12-03 | Traditional | PDF ↗ |
| K132743 | HARVESTING CANNULA | Maquet Cardiovascular, LLC | 2013-12-03 | Traditional | PDF ↗ |
| K130689 | SYMPHONY RF GENERATOR | Thermigen, Inc. | 2013-11-15 | Traditional | PDF ↗ |
| K131058 | BIPOLAR FORCEPS | Boston Endo-Surgical Technologies, Inc. | 2013-10-25 | Traditional | PDF ↗ |
| K122949 | MEDLINE SUCTION COAGULATOR | Medline Industries, Inc. | 2013-10-16 | Traditional | PDF ↗ |
| K132224 | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES | Unimed Surgical Products, Inc. | 2013-10-08 | Traditional | PDF ↗ |
| K130110 | MEDDUSA BIPOLAR SYSTEM | Elliquence, LLC | 2013-10-08 | Traditional | PDF ↗ |
| K133017 | ESTECH COBRA(R) GENESIS BIPOLAR CLAMP | Estech, Inc. | 2013-10-07 | Special | PDF ↗ |
| K131435 | ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, | Ethicon Endo-Surgery, LLC | 2013-10-03 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.