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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2017 | Teleflex Medical Percuvance Maryland Dissector Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is Terminated |
GEI | K153063 |
| Jul 19, 2017 | Teleflex Medical Percuvance Johans Grasper Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is use Terminated |
GEI | K153063 |
| Jul 19, 2017 | Teleflex Medical Percuvance Clip Applier Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used Terminated |
GEI | K153063 |
| Jul 19, 2017 | Teleflex Medical Percuvance Gripper Grasper Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is us Terminated |
GEI | K153063 |
| Jul 13, 2017 | Microline Surgical, Inc. The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic an Terminated |
GEI | K962119 K974066 |
| Jun 12, 2017 | Invuity, Inc. INVUITY(R) PhotonBlade(TM), REF PB1 Terminated |
GEI | K162053 |
| Apr 3, 2017 | Mederi Therapeutics, Inc Mederi Stretta Catheter and Accessory Kit, Sterile
For Use with the MEDERI MDRF1 GENERATOR ONLY.
Used in the treatment of gastroesophageal reflux disease (GERD).
REF 175-5580 Terminated |
GEI | K152317 |
| Feb 28, 2017 | ConMed Corporation HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 200 Terminated |
GEI | K963088 |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. T Terminated |
GEI | K963088 |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, Terminated |
GEI | K963088 |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . Terminated |
GEI | K963088 |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. T Terminated |
GEI | K963088 |
| Feb 16, 2017 | Aesculap Implant Systems LLC GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories Terminated |
GEI | K151858 |
| Jan 27, 2017 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO VH-3500
ENDOSCOPIC VESSEL HARVESTING SYSTEM
Product Usage:
The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use wi Terminated |
GEI | K153194 |
| Jan 26, 2017 | COVIDIEN MEDTRONIC Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB
Product Usage:
For use in 5mm cannulas or larger cannulas with 5mm adapters during laparos Terminated |
GEI | K964175 |
| Dec 3, 2016 | 3M Company - Health Care Business 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and
3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case)
Product Usage:
3M Universal Electrosurgical Pads are design Terminated |
GEI | K974279 |
| Dec 1, 2016 | Domain Surgical, Inc. FMsealer Open Shears. Model FM3001 Terminated |
GEI | K141484 |
| Sep 7, 2016 | Ellman International, Inc. ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE
The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpiec Terminated |
GEI | K123366 |
| Jul 18, 2016 | Bovie Medical Corporation BVX-450NR Bovie Precise 360 Handpiece 45cm, needle
Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical Terminated |
GEI | K152570 |
| Jul 18, 2016 | Bovie Medical Corporation BVX-450BR Bovie Precise 360 Handpiece 45cm, blade
Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical pr Terminated |
GEI | K152570 |
| Jul 18, 2016 | Bovie Medical Corporation BVX-330NR Bovie Precise 360 Handpiece 33cm, needle
Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical Terminated |
GEI | K152570 |
| Jul 18, 2016 | Bovie Medical Corporation BVX-330BR Bovie Precise 360 Handpiece 33cm, blade
Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical p Terminated |
GEI | K152570 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Cylindrical Tip Electrode 28CM
Item Code: E278628
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Flat L-Hook Electrode Retractable
Item Code: E2784R28ASP
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical pro Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Flat L-Hook Electrode 28cm
Item Code: E278428
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures wher Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Wire L-Hook Electrode Retractable
Item Code: E2783R36ASP
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical proc Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Wire L-Hook Electrode Retractable
Item Code: E2783R28ASP
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical proce Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Wire L-Hook Electrode 28CM
Item Code: E278328
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM
Item Code: E2782R28ASP
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Wire J-Hook Electrode 28CM
Item Code: E278228
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures wher Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM
Item Code: E2781R28ASP
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgi Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Curved Spatula Electrode 28CM
Item Code: E278128
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures w Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Straight Spatula Electrode 28CM
Item Code: E278028
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Flat L-Hook Electrode 36CM
Item Code: E277436
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures wher Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Wire J-Hook Electrode 45CM
Item Code: E277345
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures wher Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Wire J-Hook Electrode 36CM
Item Code: E277336
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Wire J-Hook Electrode 36CM
Item Code: E277236
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures wher Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Curved Spatula Electrode 45CM
Item Code: E277145
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures wh Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Curved Spatula Electrode 36CM
Item Code: E277136
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures wh Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Straight Spatula Electrode 36C
Item Code: E277036
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm
Item Code: E258328
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical proced Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM
Item Code: E258228
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedure Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM
Item Code: E258128
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical proced Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM
Item Code: E258028
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic su Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6"
Item Code: E25306
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical pr Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3"
Item Code: E25303
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical pr Terminated |
GEI | K926481 |
| Jul 8, 2016 | Medtronic Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes
Item Code: E253028
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical proc Terminated |
GEI | K926481 |
| May 31, 2016 | Integra LifeSciences Corp. Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments Terminated |
GEI | K993655 |
| May 31, 2016 | Integra LifeSciences Corp. Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments Terminated |
GEI | K993655 |
| May 18, 2016 | Conmed Corporation Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or Terminated |
GEI | K140658 |
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