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) |
|---|---|---|---|
| Aug 27, 2013 | Megadyne Medical Products, Inc. E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyes Terminated |
GEI | K913281 |
| Aug 19, 2013 | Gyrus Medical, Inc GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO.
GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO.
The Dissectors are Terminated |
GEI | K031080 |
| Jul 10, 2013 | Angiodynamics, INC AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices. Terminated |
GEI | K040989 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502
-Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288
-CAPSure 30 A Terminated |
GEI | K012669 |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Med Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured f Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Length, Product number P0118 Rx Only. Sterilized by Radiation. Ma Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufac Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured f Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Product number P0020S Rx Only. Sterilized by Radiation. Manu Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length, Product number P0100X Rx Only. Sterilized by Radiation. Manufactur Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product number P0018 Rx Only. Sterilized by Radiation. Manufactured fo Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Length, Product number P0014M Rx Only. Sterilized by Radiation. Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufacture Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured fo Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx Only. Sterilized by Radiation. Manufacture Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length, Product number P0012, Rx Only. Sterilized by Radiation. Manufactu Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured fo Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length, Product number P0014, Rx Only. Sterilized by Radiation. Manufa Terminated |
GEI | None listed |
| May 22, 2013 | Progressive Medical Inc Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiati Terminated |
GEI | None listed |
| May 22, 2013 | Unimed Surgical Products, Inc. PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm.
Intended for the cutting of soft tissue and coagulation. Terminated |
GEI | K962935 K970066 |
| Apr 2, 2013 | Medtronic Neuromodulation Medtronic Prostiva RF Therapy Generator.
The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men ov Terminated |
GEI | K113380 |
| Feb 26, 2013 | Aesculap, Inc. Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation. Terminated |
GEI | None listed |
| Feb 15, 2013 | ConMed Corporation ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA.
Intended to be used as active RF electrodes Terminated |
GEI | K800617 |
| Feb 15, 2013 | ConMed Corporation ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA.
Intended to be used as active RF electrodes for Terminated |
GEI | K800617 |
| Jan 31, 2013 | Ethicon Endo-Surgery Inc Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures.
Model Numbers:
NSLG2C14 Terminated |
GEI | K112033 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 Electrosurgical, Cutting and Coagula Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K874775 |
| Jan 24, 2013 | ConMed Corporation ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessori Terminated |
GEI | K810273 |
| Jan 24, 2013 | ConMed Corporation CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K790770 |
| Jan 24, 2013 | ConMed Corporation TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K810273 |
| Jan 24, 2013 | ConMed Corporation Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulatio Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation Terminated |
GEI | K991855 |
| Jan 24, 2013 | ConMed Corporation ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessori Terminated |
GEI | K800617 |
| Jan 24, 2013 | ConMed Corporation ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessori Terminated |
GEI | K800617 |
| Oct 24, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece
Catalog Number: 227305
The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for r Terminated |
GEI | K082643 |
| Oct 18, 2012 | Boston Scientific Corporation LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25).
Disposable, monopolar, electrosurgical devices, intended for use in conjunct Terminated |
GEI | K000032 K982556 |
| Sep 14, 2012 | Covidien LLC HALO Flex Energy Generators
Manufactured by BRRX Medical (now Covidien)
540 Oakmead Parkway
Sunnyvale, CA 95085.
The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissu Terminated |
GEI | K092487 |
| Aug 29, 2012 | Nellcor Puritan Bennett Inc. (dba Covidien LP) DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads)
The product is used during ablation surgical procedures. Terminated |
GEI | K030697 K973297 |
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