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 25, 2010 | ConMed Electrosurgery ABC PROBE REF 160644 5 mm Handswitching Probe, 44 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502... ASSEMBLED IN MEXICO
ABC PROBE REF 160636 5 mm Handswitching Probe, 44 cm QTY: Terminated |
GEI | K925903 |
| Aug 25, 2010 | ConMed Electrosurgery ABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502 ASSEMBLED IN MEXICO
ABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 10 Terminated |
GEI | K925903 |
| Aug 25, 2010 | ConMed Electrosurgery ABC PROBE REF 160656 5 mm Handswitching Probe, 28 cm QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13502 ASSEMBLED IN MEXICO
ABC PROBE REF 160656 5 mm Handswitching Probe, 28 cm QTY: 10 S Terminated |
GEI | K925903 |
| Aug 25, 2010 | ConMed Electrosurgery ABC Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label)
ABC Bend-A-Beam Ha Terminated |
GEI | K961505 |
| Aug 25, 2010 | ConMed Electrosurgery ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label)
ABC Bend-A-Beam Ha Terminated |
GEI | K961505 |
| Aug 25, 2010 | ConMed Electrosurgery ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (pouch label)
ABC Bend-A-Beam Han Terminated |
GEI | K961505 |
| Aug 19, 2010 | Starion Instruments The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/ Terminated |
GEI | K062257 |
| Aug 9, 2010 | Stryker Endoscopy Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose
Medical device indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow Terminated |
GEI | K071859 |
| Jul 9, 2010 | Starion Instruments Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA
Intended use: Med Terminated |
GEI | K062257 |
| Jul 8, 2010 | Starion Instruments Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA.
Intended use: medical de Terminated |
GEI | None listed |
| May 12, 2010 | Centurion Medical Products Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ClearVac Goldline Rocker Switch with UltraClean Blade Electrode, REF 60-6829-005A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ClearVac Goldline Rocker Switch with Blade Electrode, REF 60-6829-001A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 131327A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 131319A, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 131307A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled, Rocker Switch, Safety Holster and 10 FT Cable, Bulk, REF 130339A, Non-Sterile, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 130337A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 130327A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130319A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130307A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Tip Cleaner, Rocker Switch, Safety Holster and 10 FT Cable, REF 130304A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica Terminated |
GEI | K791137 |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Needle Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130301A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | K791137 |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, L-Wedge, 45cm, REF ES0312-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of mono Terminated |
GEI | K091074 |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monopol Terminated |
GEI | K091074 |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, L-Diamond, 35cm, REF ES0311, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monop Terminated |
GEI | K091074 |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45, Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monopolar high-fr Terminated |
GEI | K091074 |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, J-Hook, 35cm, REF ES0310, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monopola Terminated |
GEI | K091074 |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, Flat J-Hook, 35cm, REF ES0309, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of mon Terminated |
GEI | K091074 |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of mono Terminated |
GEI | K091074 |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monopo Terminated |
GEI | K091074 |
| Mar 16, 2010 | ConvaTec Neutralect Diathermy Cable,
Unomedical Ltd., Ref code 3508M, and Ref Code 3405M. Terminated |
GEI | K982130 |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide Precision Bipolar, REF PBD01, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue dissect Terminated |
GEI | K003587 |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissu Terminated |
GEI | K003587 |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue dissection, Terminated |
GEI | K003587 |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tis Terminated |
GEI | K003587 |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue di Terminated |
GEI | K003587 |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue dissectio Terminated |
GEI | K003587 |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue dissection, bip Terminated |
GEI | K003587 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Sout Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, S Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Sou Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requir Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requ Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requir Terminated |
GEI | K024286 |
| Dec 3, 2009 | Megadyne Medical Products, Inc. E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07* Terminated |
GEI | K081791 |
| Nov 10, 2009 | ConMed Electrosurgery * (Box label) SUCTION COAGULATOR 10FR QTY 25 *****
* (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE
*****
LOT 09GHL001 July 2014
MADE IN CHINA ** CONMED CORPO Terminated |
GEI | K052104 |
| Nov 10, 2009 | Kentucky Packaging Service LP Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011. Terminated |
GEI | K973234 |
| Oct 21, 2009 | Unimed Surgical Products, Inc. Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand.
Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made Terminated |
GEI | K962935 |
| Sep 9, 2009 | Linvatec Corp. dba ConMed Linvatec REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908.
ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting Terminated |
GEI | K050923 |
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