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Mild to moderate high frequency hearing loss .

The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-The RetroX Transculatieous System is mended for asso is placed via a "functional piercing" frequency hearing foss. "The Triamum "Fase "System" is processor in the outer ear canal.

The Diego RF Powered Dissector and Drill System's intended use is the cutting and removal of soft and hard tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody: - applications in the most moidectorny, polypectorny, septoplasty and - procedures such as endoscopic DCR antrostomy frontal sinus trephination and irrigation frontal sinus drill-out trans-spehnoidal procedures septal spurs removal Nasõpharyngeal/laryngeal procedures would comprise: adenoidectomy laryngeal polypectomy tonsillectomy laryngeal lesion de-bulking tracheal procedures Head & Neck procedures would encompass: soft tissue shaving rhinoplasty (narrowing of the bony vault & revision of the bony pyramid) removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face acoustic neuroma removal Otology procedures would include: mastoidectomy mastoidotomy.

The new Diego RF Powered Dissector and Drill System Console is identical to the console cleared in 510(k) # 020594 (3.08.02). However an additional panel was added to operate the current handpieces with new RF blades that can provide coagulation in addition to powered dissection. Other than coagulation during procedures, there are no new indications for use.

The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

The Hemostatix Model 2400Z Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

SMart Offset Stapes Piston Prosthesis: Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition. SMart ISJ Prosthesis: Bridging defects at the long incudal process with otherwise intact mobile chain.

SMart Offset Stapes Piston: Middle Ear Piston, Partial Ossicular Replacement Prosthesis. Utilizes nitinol wire embedded in a fluoroplastic shaft. Offered in lengths of 3.0 mm through 6.0 mm (functional length) and shaft diameters of .4, .6, .8 mm. Offset lengths between 1mm and 2mm. Supplied sterile. SMart ISJ Prosthesis: Partial Ossicular Replacement Prosthesis. Utilizes nitinol shaft and loops welded to a titanium bell. Offered in lengths of offset of 2.25 mm, 3.25 mm. Supplied sterile.

The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody: - ethmoidectomy/sphenoethmoidectomy . - polypectomy . - septoplasty and . - procedures such as . - antrostomy . - endoscopic DCR . - frontal sinus drill-out . - frontal sinus trephination and irrigation . - septal spurs removal . - trans-spehnoidal procedures . Nasopharyngeal/laryngeal procedures would comprise: - adenoidectomy ● - laryngeal lesion de-bulking ● - laryngeal polypectomy . - tracheal procedures ● - . tonsillectomy Head & Neck procedures would encompass: - . soft tissue shaving - rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) . - removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face - acoustic neuroma removal . Otology procedures would include: - mastoidectomy . - mastoidotomy .

The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.

The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

The Gyrus ENT Nerve Stimulator that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device.

The PlasmaKinetic Generator section of the GII RF Workstation is indicated for ablation of coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including: Adenoidectomy, Cysts, Head, Neck, Oral, and Sinus Surgery, Mastoidectomy, Myringotomy with effective Hemorrhage Control, Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates, Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking, Neck Mass, Papilloma Keloids, Submucosal Palatal Shrinkage, Tonsillectomy, Traditional Uvulopalatoplasty (RAUP), Tumors, Tissue in the Uvula/Soft Palate for the Treatment of Snoring. The Gyrus ENT Somnoplasty TCRF Generator section of the GII RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including: The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS; tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.

The Gyrus ENT G II RF Workstation is a combination of two previously cleared radio-frequency generators: 1. The Gyrus ENT Somnoplasty Temperature-Controlled Radio-frequency Generator -K020067, and 2. The Gyrus Medical Inc. (formerly Everest Medical Corporation) PlasmaKinetic™ Generator - K003060. The Gyrus ENT G II Radio-frequency Workstation has two modes of operation: The monopolar mode has controls for maximum temperature and energy delivered. The unit has readouts for total energy delivered, impedance, temperature for two thermocouples and time of energy delivery. The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform. Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the G II Radiofrequency Workstation include the PlasmaCision electrodes, bipolar instruments, connector cable, footswitch and a power cable.

The Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode is intended for use in the coagulation of tissues in the head and neck by qualified medical personnel trained in the use of electrosurgery. Indications for use for the Gyrus ENT Model 2420 Tissue Coagulating Electrode include the coagulation and reduction of enlarged tonsils for patients 13 years of age and older.

The Model 2420 Tissue Coagulating Electrode is used to deliver RF energy for selective thermal coagulation of tissue. The electrode is provided as a dual needle that is deployed from a guide sleeve. The angle of deployment is fixed at approximately 45°. The needle is covered proximally by insulation to protect the mucosa during coagulation. A beveled penetrator plate is located at the tip of the guide sleeve and serves to penetrate the tonsil mucosal surface prior to electrode deployment. Temperature sensors located at the tip of the needle and the tip of the insulation monitor lesion temperature. Like the previously cleared Model 1420 electrode, the Model 2420 provides a slide actuator on the handle used to extend or retract the needle electrodes through attached dual guide lumens. The proximal end of the handle accepts the detachable and reusable power cable. The distal end of the handle is attached to the guide lumens containing the needle electrodes. The entire device is disposable.

The Gyrus ENT Somnoplasty Generator, in combination with Gyrus ENT Somnoplasty Electrodes, is intended for use in the coagulation of soft tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery. The Gyrus ENT Somnoplasty Generator with the Gyrus ENT Soft Tissue Coagulating Electrodes is indicated for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The Gyrus ENT Somnoplasty Generator has controls for maximum temperature, energy delivered and time of energy delivery. The unit readouts for total energy delivered, has temperature for two impedance. and thermocouples. Connectors on the front panel include connector for active electrode and dispersive electrode. The foot pedal is connected on the back panel. Accessories included with the generator are a power cable and a footswitch.

The Diego Powered Dissector and Drill System's intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody: - ethmoidectory/sphenoethmoidectomy . - polypectomy . - septoplasty and . - procedures such as . - antrostomy ● - endoscopic DCR . - frontal sinus drill-out . - frontal sinus trephination and irrigation ● - septal spurs removal . - trans-spehnoidal procedures . Nasopharyngeal/laryngeal procedures would comprise: - adenoidectomy . - laryngeal lesion de-bulking . - laryngeal polypectomy . - tracheal procedures ● - tonsillectomy . Head & Neck procedures would encompass: - soft tissue shaving . - rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) . - minopial of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face - acoustic neuroma removal . Otology procedures would include: - mastoidectomy ● - mastoidotomy. .

The Diego Powered Dissector and Drill System is an Electrical Surgical Drill/Shaver. It consists of a console with a separate footswitch and integrated irrigation pump. It supports 4 handpieces (Diego, Stapes, and Viper Straight and Angled). The console is controlled by an 8-bit Microprocessor. The handpieces have suction capability for the Shaver Handpiece and no suction for the Drill Handpiece. Irrigation capability is present with the exception of the Stapes Drill Handpiece. The chucking mechanism varies by handpiece type. The system is sterilizable by Autoclave or EO.