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The Electrohydraulic Lithotriptor is intended to be used with Potent Medical disposable electrohydraulic lithotripsy (EHL) probes for disintegration of concernments in the bile duct.

The EHL is a compact, table-top medical device designed for the fragmentation of biliary calculi. It operates by generating high-voltage electric pulses, which are transmitted through a compatible disposable EHL probe (sold separately) that is inserted into the biliary tract via an endoscope. The device features two operational modes: single pulse and continuous pulse. These electric pulses create hydraulic shock waves in a saline medium, causing fragmentation of biliary stones into smaller pieces that can either be naturally passed or removed endoscopically.

The EHL probe is designed for use with Potent Medical Electrohydraulic Lithotripter (TCS-B3-II) for disintegration of concernments in the bile duct.

The SCDG -AS, SCDG -BS, and SCDG CS are sterile, single-use electrohydraulic lithotripsy (EHL) probes. These probes are designed to be used with the Electrohydraulic Lithotripter (TCS-B3-II) for the fragmentation of biliary calculi. The probes deliver low-energy electrical pulses through a dedicated connection to the generator, generating hydraulic shock waves in a saline medium to fragment stones in the biliary tract.

The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2) shock wave alone; or 3) combined ultrasound and shock wave.. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a dual-energy reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal. The purpose of this 510(k) is to increased the number of validated reprocessing cycles for the reusable handpiece and add the option of a wireless foot pedal.

The EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.

The EL27-Compact is a device, designed to be used with Walz Elektronik GmbH disposable EHL-Probes for the fragmentation of concrements in the gastroenterology and urology. A physician inserts and pushes the disposable EHL probe through the working channel of an endoscope and places the tip of the probe in front of the stone surrounded with saline solution. With pressing the footswitch, the device provides electric pulse energy in form of a high-voltage pulse. This pulse generates high pressure shockwaves that fragment hard stones. The EL27-Compact is a table-top device and consists of the generator itself, the power cord, the footswitch, a probe cable for connection between the device and the EHL-probes.

The Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH® URO-TOUCH unit/generator for the fragmentation of renal calculi located in the kidneys and urinary bladder.

The Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH® URO-TOUCH unit/generator for the fragmentation of calculi located in the kidneys and urinary bladder. The Northgate Technologies Inc. AUTOLITH® URO-TOUCH System consists of a software controlled, electronic unit (Generator) which generates a single high-voltage pulse or a series of pulses across the tip of a flexible bipolar lithotripter probe. When discharged in 0.9% normal physiological saline solution, these pulses produce sharp, high-amplitude hydraulic shock waves that crack calculi (stones) located inside the body. They are capable of cracking calculi of virtually any size and composition. The objective is to reduce the size of the calculi so that fragments can be removed without major surgery. The AUTOLITH® URO-TOUCH System includes the following major components: AUTOLITH® URO-TOUCH Unit/Generator (K130368) Regulate the discharge voltage and repetition rate of a shot delivered to a connected extender cable and probe. Display the relative power delivered to the probe. Display the number of pulses to be delivered to the probe as requested by the operator. Automatically sense the existence of a plugged-in probe. Automatically preset start-up values for power and pulses according to the probe type. Automatically scale power range according to the probe type. Prohibit discharge of high voltage when the footswitch is activated if an extender cable/probe is not properly connected. Automatically compares the pulses delivered at the selected power levels and displays when to INSPECT or REPLACE PROBE. Displays the number of pulses delivered. Automatic AC Voltage Adjust. For use in all countries. The AUTOLITH® URO-TOUCH 9 Fr Probe is 54 cm long and is used with a transurethral scope for fragmentation of calculi in the kidneys and urinary bladder. The 9 Fr Probe, 54 cm long, was previously cleared by K914516 on January 7, 1992. The Extender Cable was cleared by K914517 on June 30, 1992.

The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2) shock wave alone; or 3) combined ultrasound and shock wave.. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a dual-energy reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy has three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Triloqy is an intracorporal lithotripter with three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy has three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

The Swiss LithoClast® Trilogy is a modified version of the Swiss LithoClast® Master, previously cleared under K012445. As with the predicate device, three possible modes of operation are available: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.