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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 ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The ELLAVI UBT is an 18 cm long intrauterine balloon tamponade device primarily comprised of thermoplastic elastomer. The balloon and internal tubing are made of thermoplastic elastomer, while the exterior tubing is made of polyvinyl chloride. A supply bag is the filled, connected, and hung at a pre-determined height based on the patient's systolic blood pressure. The device consists of a balloon that is inserted into the uterus transvaginally into the postpartum uterus after delivery and removal of the placenta. A valve is then opened, and this allows the fluid to inflate the balloon and apply pressure to achieve a hemostatic effect.

The Apyx is intended for attaching sutures to ligaments of the pelvic floor.

The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor / suture assembly is deployed to the target site from the cartridge with an applicator. An optional use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing. The Apyx device is a single use device which is supplied sterile.

The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.

The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only. The wee Bell is designed to assist in the performance of a circumferential crushing of the foreskin (prepuce) by tightening the ligature around the bell portion of the device. The remaining foreskin is then removed. The wee Bell is comprised of two components: a transparent plastic bell and a ligature. It is available in six (6) sizes to accommodate anatomy variation in the size of newborn and infant glands. The device is EtO sterilized and is a single-use device.

The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.

Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.

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 Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.

The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only. The Konig Mogen Clamp consists of an arm with a locking mechanism in order facilitate compression on the foreskin. The locking mechanism consists of a lock connected to a lock bar using a pin. The clamp is fixed with a spot welding point, which allows for a maximum opening of 2.5 mm. The edges of the closing area are chamfered and rounded to avoid tissue injury. The Konig Mogen Clamp is a reusable instrument that is provided non-sterilyzed by the user. The Konig Mogen Clamp will be validated for use in pre-vacuum steam sterilization.

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.