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The EVIS Bronchofibervideoscope Olympus BF type XP160F has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

The subject device, EVIS EXERA Bronchofibervideoscope Olympus BF type XP100F is basically The Subject device, EVIC EXER & Bronchofiberscope Olympus BF type XP40 (BF-XP40) licentical to the predicate device, OEO Bronth hise copy othe control section. The fiber partners them except that the subject dovice to equipped with the control section, and the CCD changes them the insection tube transmite thay of the subject device is equivalent to the combination of the BF-XP40 to video Signals: In printiple, the stayss OVC-200. The CCD equipped with the subject device is and the OLO Video Onvortor Offinial Orympas Oronchovideoscope Olympus BF type 160 (BF-160). By licentical to that of the EVTO EXER & Erenonention tube diameter of the subject device Combining the OOD in the Boops o on comparison with the BF-XP40, the performance of is han ower than that of the essary to attach the video converter.

OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general (open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3). - (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series. - (2) Olympus SonoSurg Transducer SonoSurg-T2H. - (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51). This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.

This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, display monitor, strobe light source specified by OLYMPUS, and ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy.

The subject device, the VISERA Rhino-Larvngovideoscope Olympus ENF type V is identical to the predicate device cleared in #K021073. This premarket notification is submitted to expand the intended use to add compatibility with strobe light sources specified by Olympus and change the applications from the nasal and nasopharyngeal lumens and airway and airway anatomy. Olympus specifies the Light Source Model 9100 B and 9100 C (#K921184) manufactured by Kay Elemetrics corp., for endoscopic diagnosis using the strobe light source.

This instrument has been designed to be used with an Olympus Light Source, documentation equipment, display monitor, suction pump, Endo-Therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

The subject device, the XCYF-TP3 is basically identical to the predicate device (XCYF-1T3) which is the flexible endoscope for use in the bladder, urethra and kidney. Subject device may be used with three different Light source as follow, · A rechargeable powered Miniature Light source, or, · A battery powered Miniature Light source as predicate device, XENF-DP, or, · Light guide cable as predicate device, XENF-DP. In conclusion, this subject device is technically the same as the predicate device, which we describe in the table above.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Trans-esophageal(non-cardiac) Other 1) Gastrointestinal tract and the surrounding organs

These subject devices have been designed to be used with the HDI5000 Ultrasound system (Philips Ultrasound), Olympus video system center, light Source, documentation equipment, video monitor, endo-therapy accessories such as an aspiration biopsy needle and electrosurgical unit except for endoscopic ultrasound (EUS) guided electrosurgery. These subject devices are designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper gastrointestinal tract and surrounding orgains.

-Heat scissors generator set The Heat scissors generator set has been designed to generate electrical energy to the Heat scissors handpiece to cut and coagulate body tissue. -Heat scissors handpiece (XRF-940-M) The Heat scissors handpiece has been designed to cut and coagulate body tissue in general (open) abdominal surgery.

The Heat scissors system has been designed to cut and coagulate tissue for general (open) abdominal surgery. This system consists of the Heat scissors generator, Heat scissors handpiece and foot switch. This system uses direct thermal energy and simultaneous pressure to cut and coagulate tissue. The thermal energy is generated at the Heat-generating section of the blade, on the Heat scissors handpiece. It is conveyed via a non-stick coating on the blade to the tissue.

This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for bronchial endoscopic treatment (cutting and coagulating) including: - Hemostasis of superficial bleeding - Treatment of benign tumors like papillomatosis, granulomas, polyps, lipomas and hemangiomas in the trachea and bronchi - Recanalization of malignant stenoses - Treatment of Cicatricial stenoses of the respiratory tract

This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for bronchial endoscopic treatment (cutting and coagulating. Recommended endoscopes for this instrument are Olympus's series BF series, and Olympus's electrosurgical instruments such as electrosurgical snare, hot biopsy forceps. Other Olympus electrosurgical devices or instruments can be used with this subject device. Be sure to check compatibility for each device in each instrument's instruction manual. The PSD-20 unit offers Monopolar output modes; 5 Cut modes (PURE, BLEND 1/2/3/4), 1 Coagulation mode. (NORMAL COAGULATION), It offers several features to ensure the safe operation of the unit. For example, the voltage output level setting and a monitor circuit detect irreqularity or improper connections.

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus, including: - Abnormal uterine bleeding - Evaluation of abnormal hysterosalpingogram - Evaluation of abnormal ultrasound image - Infertility and pregnancy wastage - Pelvic pain

This subject device is videoscope used for diagnosis within the uterus. New type of CCD is lead to be more easier observation and diagnosis. In HYF-V, a light guide connector and a video connector are separated each other. The light guide connector is to connect with a light source and the video connector is with a video system center.

The XTJF-160AF has been designed to be used with an Olympus EVIS video system center, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum. Do not use these instruments for any purpose other than their intended uses.

This premarket notification is proposed to establish the safety and effectiveness of the variable stiffness scope that is intended for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum. The intended use of the XTJF-160AF is identical to that of previously cleared device, the TJF-140R and JF-V10. The mechanical structure of variable stiffness is identical to that of another predicate device, the EVIS EXERA Colonovideoendoscopes. While the variable stiffness scope is brand new device in the duodenum, endoscopy and endoscopic surgery, including electrocautery, within the duodenum is popular and the mechanical structure of variable stiffness has been confirmed to be safe by the EVIS EXERA Colonovideoendoscopes. Any new insertion method or techniques in consequence of the added mechanical structure of variable stiffness are not considered. Therefore, this modification does not affect the safety and effectiveness of the proposed device, XTJF-160AF has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-2 and IEC60601-2-18. There are no new patient contacting materials. All of patient contacting materials is cleared by previous 510(k). And all materials have been confirmed with ISO 10993-1.

This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating) including: - Hemostasis of superficial bleeding - Treatment of bladder tumors - Treatment of stenosis inside urinary tract.

This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating). Recommended endoscopes for this instrument are Olympus's series CYF series, and Olympus's electrosurgical instruments such as electrosurgical snare, hot biopsy forceps. Other Olympus electrosurgical devices or instruments can be used with this subject device. Be sure to check compatibility for each device in each instruction manual. The PSD-20 unit offers Monopolar, output modes; 5 Cut modes (PURE, BLEND 1/2/3/4), 1 Coagulation mode, (NORMAL COAGULATION), It offers several features to ensure the safe operation of the unit. For example, the voltage output level setting and a monitor circuit detect irreqularity or improper connections.