Panels › General, Plastic Surgery › Product code GEI · Class 2
Electrosurgical, Cutting & Coagulation & Accessories
Regulation 878.4400
47510(k)s in 12 months (2,321 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
Top companies in GEI
| Company | 510(k)s | Recalls |
|---|---|---|
| ArthroCare Corporation | 86 | 5 |
| Conmed Corporation | 25 | 53 |
| Valleylab | 69 | 0 |
| Megadyne Medical Products, Inc. | 32 | 31 |
| Covidien | 41 | 14 |
| Carefusion 2200, Inc. | 2 | 45 |
| Stryker | 9 | 35 |
| Conmedcorp | 43 | 0 |
| Gyrus Acmi, Inc. | 21 | 20 |
| Bovie Medical | 21 | 15 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2015 | K150835 | LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip Covidien | GEI |
| Oct 9, 2015 | K151044 | CLICKLINE Scissor Insert for Single Use Karl Storz Endoscopy America, Inc. | GEI |
| Oct 8, 2015 | K134036 | WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT Loktal Medical Electronics Ind. Com. Ltda- Epp | GEI |
| Sep 23, 2015 | K152317 | Stretta Catheter Mederi Therapeutics, Inc. | GEI |
| Sep 17, 2015 | K152031 | New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connect New Deantronics Taiwan , Ltd., TW | GEI |
| Sep 10, 2015 | K151649 | Valleylab FT10 Electrosurgical Platform Covidien | GEI |
| Sep 10, 2015 | K150959 | Sutter Bipolar Forceps-Calvian Sutter Medizintechnik GmbH, DE | GEI |
| Sep 10, 2015 | K150112 | HS AMICA DEVICES FAMILY H.S Hospital Service S.P.A, IT | GEI |
| Sep 8, 2015 | K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider Covidien | GEI |
| Aug 4, 2015 | K151325 | Bovie J-Plasma Handpiece Bovie Medical Corporation | GEI |
| Aug 4, 2015 | K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot Covidien | GEI |
| Jul 28, 2015 | K150251 | Barrx Anorectal RFA Wand Covidien, LLC | GEI |
| Jul 21, 2015 | K151858 | Caiman Seal and Cut Technology Aesculap, Inc. | GEI |
| Jul 20, 2015 | K151696 | Caiman Seal and Cut Technology Aesculap, Inc. | GEI |
| Jul 16, 2015 | K143103 | PROPENCIL Smoke Pencil Bio Protech, Inc., KR | GEI |
| Jun 24, 2015 | K150029 | Habib EUS RFA Emcision , Ltd., GB | GEI |
| Jun 16, 2015 | K142480 | OsteoCool V-2 RF Ablation System Baylis Medical Company, Inc., CA | GEI |
| Jun 11, 2015 | K143559 | XP1000 RF BTL Industries, Inc. | GEI |
| May 28, 2015 | K150824 | TD-Wand Tdm Surgitech, Inc. | GEI |
| May 22, 2015 | K151222 | Cautery Tip Cleaner Key Surgical, Inc. | GEI |
| May 21, 2015 | K150297 | PlasmaBlade UPPP and Suction Coagulator Medtronic Advanced Energy | GEI |
| May 12, 2015 | K150161 | Venus Viva SR Device Venus Concept , Ltd. | GEI |
| Apr 23, 2015 | K150993 | NICO TRIOwand Nico Corporation | GEI |
| Apr 16, 2015 | K143536 | Voyant Fine Fusion Device Applied Medical Resources | GEI |
| Apr 13, 2015 | K142208 | Monopolar Laparascopic Accessories Unimicro Medical Systems (Shenzhen) Co., Ltd., CN | GEI |
| Apr 3, 2015 | K143654 | Valleylab LS10 Generator Covidien, LLC | GEI |
| Apr 3, 2015 | K143475 | VAPR Tripolar Suction Electrode Depuy Mitek | GEI |
| Mar 27, 2015 | K143517 | Voyant Open Sealer-Divider Device Applied Medical Resources | GEI |
| Mar 12, 2015 | K143662 | Bissinger Monopolar Forceps and Cables Medagent, Inc. | GEI |
| Mar 6, 2015 | K143109 | XP300 BTL Industries, Inc. | GEI |
| Mar 6, 2015 | K141790 | AQANIFE Ovesco Endoscopy AG, DE | GEI |
| Feb 20, 2015 | K150024 | Bissinger Monopolar Cables Guenter Bissinger Medizintechnik GmbH, DE | GEI |
| Feb 20, 2015 | K142248 | Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Urologix, Inc. | GEI |
| Feb 18, 2015 | K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER Megadyne Medical Products, Inc. | GEI |
| Jan 27, 2015 | K142929 | Ligasure Blunt Tip Sealer/Divider Covidien | GEI |
| Jan 13, 2015 | K142759 | PK Cutting Forceps for ESG-400 Workstation Gyrus Acmi, Inc. | GEI |
| Jan 8, 2015 | K142350 | PK J-HOOK Gyrus Acmi, Inc. | GEI |
| Jan 2, 2015 | K142229 | Laparoscopic FMsealer Domain Surgical, Inc. | GEI |
| Dec 31, 2014 | K143175 | AEx Generator; PlasmaBlade T Medtronic Advanced Energy | GEI |
| Dec 31, 2014 | K142289 | PK Spatula Gyrus Acmi, Inc. | GEI |
| Dec 19, 2014 | K143161 | Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) Covidien | GEI |
| Dec 19, 2014 | K142910 | Legacy BX Venus Concept USA, Inc. | GEI |
| Dec 19, 2014 | K142154 | PK NEEDLE Gyrus Acmi, Inc. | GEI |
| Dec 12, 2014 | K142975 | Bovie Ultimate High Frequency Electrosurgical Generator Bovie Medical Corporation | GEI |
| Dec 10, 2014 | K140624 | HICURA HAND INSTRUMENTS Olympus Winter & Ibe GmbH | GEI |
| Dec 8, 2014 | K141507 | TWO SKIN TREATMENT SYSTEM Syneron Medical, Ltd. | GEI |
| Dec 4, 2014 | K143145 | SafeAir Smoke Pencil Lina Medical Aps, DK | GEI |
| Dec 3, 2014 | K140926 | INMODE WMFACE DEVICE Inmode MD , Ltd., IL | GEI |
| Nov 21, 2014 | K142868 | 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Purple Surgical International Limited, GB | GEI |
| Nov 21, 2014 | K134006 | DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE Modern Medical Equipment Manufacturing Limited, CN | GEI |
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