Search Results

The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector. The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure. The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure. The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures. The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve. These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).

The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector. The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure. The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure. The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures. The Connector allows attachment between the irrigation tubset via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water jet valve. These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The Single Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The Single Use Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure. The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit). The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel postprocedure, and not to be used during a patient procedure.

The Defendo Fujifilm 700 Single-Use Valves Set consists of a family of ready-to-use, sterile, single-use valves designed to be used on the Fujifilm 700 series GI endoscopes as accessories. The specific valves that are the subject of this 510(k) include the Defendo Fujifilm 700 Single-Use Air/Water Valve, the Defendo Fujifilm 700 Single-Use Suction Valve, the Defendo Fujifilm 700 Single Use Biopsy Valve, the Endogator Fujifilm 700 Connector, and the Defendo Fujifilm 700 Cleaning Adapter.