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The Gynecare TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device. The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.

The Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant. The Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly. The Winged Guide is a stainless steel accessory instrument that facilitates consistent passage of the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly through the dissection tract.

The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically. The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitation of the urethra and bladder neck during the placement of the GYNECARE TVT Device and GYNECARE TVT EXACT Continence System. The GYNECARE TVT EXACT™ Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.

The subject devices include the following components: GYNECARE TVT™ Reusable Introducer GYNECARE TVTTM Reusable Rigid Catheter Guide GYNECARE TVT EXACT™ Continence System Trocar The subject devices are intended to be used with the GYNECARE TVT™ Device and GYNECARE TVT EXACT™ Continence System intended to treat stress urinary incontinence. GYNECARE TVT™ Reusable Introducer The GYNECARE TVT™ Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT™ Device from the vagina to the abdominal skin. It is connected and fixed to the threaded end of the shaft, prior to inserting the needle with the tape. GYNECARE TVT™ Reusable Rigid Catheter Guide The GYNECARE TVT™ Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Folev catheter (recommended size 18 French) positioned in the urethra. To facilitate insertion, it can be lubricated with gel. GYNECARE TVT EXACT™ Continence System Trocar The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.

The GYNECARE TVT™ Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT™ device when placed in a top-down retropubic fashion (also known as an abdominal approach). The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT™ device retropubically. The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitation of the urethra and bladder neck during the placement of the GYNECARE TVT™ device.

The subject devices included the following components: GYNECARE TVT™ Reusable Introducer GYNECARE TVT™ Reusable Rigid Catheter Guide GYNECARE TVT™ Abdominal Guides and Couplers The subject devices are intended to be used with the GYNECARE TVT™ sling intended to treat stress urinary incontinence. GYNECARE TVT™ Reusable Introducer: The GYNECARE TVT Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT Device from the vagina to the abdominal skin. It is connected and fixed to the needle, via the threaded end of the shaft, prior to inserting the needle with the tape. GYNECARE TVT™ Reusable Rigid Catheter Guide: The GYNECARE TVT Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Foley catheter (recommended size 18 French) positioned in the bladder via the urethra. To facilitate insertion, it can be lubricated with gel. GYNECARE TVT™ Abdominal Guide: The GYNECARE TVT abdominal guide is a sterile disposable instrument intended to facilitate passage of the GYNECARE TVT device. Two abdominal guides are included in each kit with the GYNECARE TVT couplers. GYNECARE TVT™ Coupler: The GYNECARE TVT coupler is a sterile disposable polypropylene connector used to connect the GYNECARE TVT abdominal quide to the GYNECARE TVT needle. Two couplers are included in each kit with abdominal quides.

The Caldera Medical surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence. Caldera Medical Outside-In introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL), Desara® Blue SS (CAL-DS01BS) Caldera Medical Inside-Out introducers may be used with or without the Winged Guide Accessory with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL) Caldera Medical Suprapubic introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® Blue SS (CAL-DS01BS) Caldera Medical Transvaginal introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV) Desara® TV (CAL-DS01TV), Desara® Blue TV (CAL-DS01BTV) implants may only be used with Caldera Medical Transvaginal introducers, CAL-TV32

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The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures. The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures. The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures. The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures. The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures. The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures. The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures. The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.

The subject devices are not sold individually and are only offered packaged as part of a surgical mesh system. Device descriptions specific to each delivery device are italicized below within each existing system description. Advantage™ System and Advantage Fit™ System: The disposable delivery device consists of a handle with a curved needle, and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for transvaginal placement. Lynx™ System: The disposable delivery device consists of a handle with a curved needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement. Solyx™ SIS System: The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle. Obtryx™ System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen. Obtryx™ II System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.