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FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.

Use of the RELIEEV Uterine Manipulator Injector is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty procedures where manipulation of the uterus is required.

The "RELIEEV" Uterine Manipulator Injector is intended to be used during medical procedures where manipulation of the uterus or injection of fluids into the uterine lumen are needed. This device is a sterile, single use product consisting of a plastic (PVC) insertion tube that includes two lumens, one for inflation of a 10 mL intrauterine balloon (cuff) at the distal end of the insertion tube via the inflation valve using the provided 10 mL syringe and the other for injection of fluid through a distal end-port using a user-provided syringe via the Leur fitting. The device also includes a movable/removable rigid handle that allows alteration of the device insertion depth and includes a cervical stop, laser etched depth markings to aid in setting the insertion depth, and a pilot balloon to assess maintenance of cuff inflation. The device is curved to facilitate forward uterine manipulation. The device has an overall length of 36 cm and an outer diameter of the catheter component of 5.0 mm. When inflated with 10 mL of air, the balloon has a diameter of 23.0-24.9 mm.

FemChec® is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

FemChec® is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via EO sterilization and is intended for single-use.

The Rejoni Intrauterine Catheter is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG. the Rejoni Intrauterine Catheter can be used for evaluation of tubal patency. The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

The Rejoni Intrauterine Catheter is a sterile, single lumen uterine catheter that facilitates access to the uterus to deliver fluids during Hysterosalpingography (HSG) or Sonohysterography (SHG). The Rejoni Intrauterine Catheter consists of an inner shaft and an additional support sheath over the proximal portion of the catheter shaft to provide additional stiffness. A repositionable stopper ("acom") is connected to the support sheath, which is placed on the catheter shaft, and can be repositioned from 0 cm up to 10 cm from the distal tip of the catheter. The stopper maintains placement of the catheter against the external cervical os during the procedure, and a luer lock-style adapter on the proximal end is available for compatibility with syringes. The distal end contains a straight through hole for delivery of fluids during the procedure.

The ALLY II UPS™ (Uterine Positioning System) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.

The ALLY II UPS™ (Uterine Positioning System) attaches to the operating room table and enables the bed-side assistant to readily mount, hold, and position the manipulator during laparoscopic surgical procedures. The ALLY II UPS enables access and provides the ability to maneuver and maintain the manipulator in a desired position. The ALLY II UPS consists of the ALLY II UPS and a manipulator adapter with built-in sterile drape, known as the adapter drape. The CooperSurgical ALLY II UPS is a non-patient contacting, electromechanical device that consists of a single, multi-segmented, articulated arm. The ALLY II UPS can be attached to the standard operating room bed rail, and a separate, sterile, disposable Adapter Drape that is used to attach a uterine manipulator to the ALLY II UPS. When unlocked, the flexible arm allows the attached manipulator to be positioned by the user. The arm can then be locked in the desired position by releasing a foot pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator. The purpose of this submission is to gain clearance for minor modifications made to the ALL Y Uterine Positioning System to meet user needs and allow for user convenience. The overall functionality and interface of the ALLY II UPS for the user remains the same.

The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.

The Uterine ElevatOR PRO with OccludOR Balloon™ is a sterile, single-use medical device used to manipulate the uterus and cervix in surgical and diagnostic procedures. The device includes an insulated and anatomically designed stainless steel shaft with an intrauterine balloon and reference graduations (centimetres) at the proximal [to patient] end and an external handle at the distal end. The intrauterine balloon is inflated with air using a standard syringe (not included). The device has a vaginal cup that is pushed along the shaft to support a green cervical cup. The cervical cup provides a guide for colpotomy. There are four sizes of cervical cups available, 32mm, 37mm, and 40mm, which correspond to the different model numbers. A locking assembly secures the position of the vaginal cup and therefore the cervical cup. Sites for suturing are located on the cervical cup. An Occluder Balloon further reduces leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.

The use of the DUMI ManipulatOR is indicated in diagnostic laparoscopy, mini laparotomy, fertility exams, and salpingoplastic procedures where manipulation of the uterus is required.

The DUMI ManipulatOR is a sterile, single use, disposable medical device designed for the intra-operative manipulation of both the anteverted and retroverted uterus as well as facilitating simple and effective dye studies. The device includes an anatomically designed balloon at the distal end that is injected with air by syringe through the luer connector of inflation valve. The three-way hub can accommodate fluid and can be used for dye studies.

The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6 French in diameter to access the uterine cavity for assessment of tubal patency. The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.

The IAB and SSG Catheters facilitate access to the uterus and tubal ostium to deliver contrast media during diagnostic procedures. The IAB Catheter is 9 French (Fr) in diameter and has a 23 cm working length. It is designed with a polyurethane shaft and a silicone distal balloon with a 2-cc inflation volume. The catheter includes two lumens, one for balloon inflation and the other can be used to inject contrast medium into the uterus for hysterosalpingography (HSG) and as an access channel that accepts devices up to 6 Fr in diameter for use in assessing tubal patency. The Intrauterine Access Balloon Catheter is packaged with a shipping stylet and a 3 mL syringe that is used to inflate the balloon with sterile media. The SSG Catheter is manufactured from braided polyethylene and is designed with an angled distal tip with a radiopaque tungsten band. The catheter is 5.5 Fr in diameter and has a 40 cm working length. The SSG Catheter is intended to be used through a dimensionally compatible access catheter (IAB Catheter) to gain access to the uterine cavity for a more selective visualization of the fallopian tubes when positioned at the tubal ostium. Both devices are supplied sterile (ethylene oxide) and are intended for single-use only.

The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.

The Cook® Silicone Balloon HSG Catheter is a dual lumen polyurethane catheter that is manufactured in 5.0 or 7.0 French (Fr) sizes and is 30 cm in length. The Cook® Silicone Balloon HSG Catheter is available with an open-end tip, or a closed-end tip with a single side port. The silicone balloon is designed with a balloon volume of 1.0 mL (5.0 Fr) or 1.5 mL (7.0 Fr). Depending upon the device a 1 or 3 mL syringe is provided with the balloon catheter. The Cook® Silicone Balloon HSG Catheter will be supplied sterile (ethylene oxide) and is intended for one-time use. The set is packaged in a peel-open pouch. The 5.0 Fr size catheter has a three-year shelf-life, and the 7.0 Fr size catheter has a two-year shelf-life.

The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency. The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

The Margolin HSG Cannula and Goldstein Sonohysterography Catheter are single lumen uterine catheters that facilitate access to the uterus to deliver fluid (contrast media or saline) during diagnostic procedures. Both feature a silicone "acom" wedge that seals the cervical canal and maintains the position of the catheter during the procedure.