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The LAP-WAVE 3000 (P07) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation.

The LAP-WAVE 3000 (P07) (K990732) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation. Irrigation fluid is transported from the fluid container to the instrument inserted in the patient by means of a roller-wheel pump at the device and a disposable PVC tubing set. A trumpet valve instrument (not provided with device) is used to manipulate the flow of fluid into the patient. A pressure sensor at the device is used to regulate pressure at the instrument (trumpet valve). Irrigation is initiated by opening the instrument and discontinued by closing the instrument. Also, a tubing set for connection to a central suction system is provided with the device to allow for removal of the fluid from the patient.

The Arthro-Surgimat-2000 ECU is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle and wrist joint cavities under optional voice-activation control during arthroscopic procedures. (21 C.F.R. & 888.1100).

The ARTHRO-SURGIMAT-2000 ECU is a high flow arthroscopic pump intended to distend joint cavities. The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the device Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. GmbH. W.O.M. also claims substantial equivalence to the Surgiflator-20 ECU (K981859) and the Linvatec Apex Universal Inrigation System (K933873). With the exception of the following modifications, the ARTHRO-SURGIMAT-2000 ECU incorporates the same design features and accessories as the Arthro-Surgimat-1500 (K983910): - A serial interface has been incorporated in the device to allow for surgeon selection of device settings ● utilizing the HERMES Operating Room Control Center (K980787). The external adjustment capability of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Surgiflator-20 ECU (K981859) manufactured by W.O.M. GmbH - The maximum flow performance of the device has been increased from 1,5 Vmin. to 2 Vmin. The . flow performance of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Apex Universal Irrigation System (K933873) manufactured by Linvatec Corp.

The HYS-Surgiflator 150P is a hysteroscopic insufflator intended to distend the uterus by fillng the uterine cavity with a gas to facilitate viewing with a hysteroscope (21 C.F.R. § 884.1700).

The HYS-Surgiflator 150P is a hysteroscopic insufflator. It is substantially equivalent to the Hysteroflator OP, K922632/B, manufactured by W.O.M. GmbH. Differences include: reduced max. intrauterine pressure (150 mm Hg), preselection of desired pressure (15 - 150 mm Hg), incorporation of a venting valve for automatic pressure regulation, incorporation of an audible and visible overpressure alarm, and required use of a hydrophobic filter.

The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle, and wrist joint cavities during arthroscopic procedures.

The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended to distend joint cavities. The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114) manufactured by W.O.M. GmbH. The Arthro-Surgimat-1500 incorporates the same design features and accessories as the Arthro-Surgimat (K962114). The following modifications have been performed: 1. The device Arthro-Surgimat-1500 incorporates a software filter function referred to as the instrument recognition feature. The instrument recognition feature of the device measures the resistance of the tubing set and instrument being used and regulates the actual pressure accordingly. The instrument recognition feature of the device allows for a more accurate attainment of the desired intraarticular pressure. 2. The device Arthro-Surgimat-1500 incorporates an optional cable remote control for the adjustment of device parameters. Only those parameter which may be adjusted utilizing the user-interface (front panel) and the foot pedal may be adjusted utilizing the cable remote control.

intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic vísualization

The Surgiflator-20 ECU described in this notification is a modified version of and substantially equivalent to the Surgiflator 20-PIM (K955791) which is manufactured by W.O.M. GmbH. The Surgiflator-20 ECU incorporates the same design features as the Surgiflator-20 PIM. The only difference is that the function adjustment feature of the Surgiflator-20 ECU has been modified. The modification consists of a serial interface to allow for surgeon selection of device settings utilizing the HERMES Operating Room Control Center (K980787).

To facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

The Surgiflator-30 is a laparoscopic high flow insufflator intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. The Surgifiator-30 incorporates the same design features as the W.O.M. Surgifiator 20-PIM. The only differences lie in the following: Surgiflator-30 offers an increased flow rate of max. 30 Vmin. The device will also be available as a 25 Vmin version. The Surgifiator-30 does not offer optional simultaneous pressure monitoring.

The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO2 to enable laparoscopic procedures.

The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO2 to enable laparoscopic procedures. The Surgiflator-20 PIM described in this notification is similar in design and construction to the W.O.M. Surgiflator 20, K950035 and the Snowden-Pencer High Flow Insufflator, Model 89-8600 and Model SP 88-9700, distributed in the United States by Snowden-Pencer, Inc. The Surgiflator-20 PIM incorporates the same design features as the W.O.M. Surgiflator 20. The differences lie in the following features: Low pressure insufflation mode - fills the abdomen more gently; Fluid sensor: shows the user when the device is contaminated by backflow; Simultaneous pressure monitoring: monitoring of the pressure directly in the abdomen.

The Arthro-Surgimat is a high flow arthroscopic pump classified under 21 C.F.R. § 888.1100 intended to distend joint cavities during arthroscopic procedures.

The Arthro-Surgimat is a high flow arthroscopic pump designed to react very quickly to various influences, thereby maintaining constant intraarticular pressure. It has pressure measurement through multiple sensors at the pump head, 3 optional preselectable pressure levels (to be programmed by end-user), a max. flow rate of 1500 ml/min, and a foot pedal for temporary increase of preselected flow level for rinsing of joint after/during shaver use.