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Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for male patients only (adults and pediatric above the age of 1 years).

The Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation. The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products. The Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

Luja Set is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for male patients only (adults and pediatric above the age of 1 years).

The medical device is an intermittent, ready-to-use, sterile, hydrophilic-coated catheter with integrated urine bag. It contains a catheter with a flexible tip that facilitates passage through the sphincter in the urethra. The catheter is shielded by a sleeve, which serves as protection from the user's hands during insertion. Several small holes (micro-holes) by the straight tip, create a draining zone, which allow the urine to flow from the bladder out through the catheter to a urine bag. The drainage end of the catheter is attached to a urine bag with a tear off section to open the bag for emptying. The catheter is sterilized by radiation. The Luja Set is available in sizes: CH10, CH12, CH14, and CH16.

The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

SureCath Set is a sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag. An ampoule of saline solution is provided inside the urine bag. This saline solution from the ampoule is poured over the catheter to activate the coating before use.

Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for male patients only (adults and pediatric above the age of 1 years).

Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation. The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products. Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The ReTrace Ureteral Access Sheath is a sterile, single use device that is inserted over a guidewire into the upper or lower urinary tract of patients requiring ureteroscopic procedure sin a hospital environment. The ReTrace Ureteral Access Sheath consists of: - Reinforced tube/sheath - Introducer/dilator - Connector - Clip The reinforced polymeric introducer sheath includes a hydrophilic coating on the exterior and a lubricious inner surface. The sheath is reinforced to provide kink resistance. The distal tip of the sheath is fitted with a radiopaque ring. A white connector is fitted on the proximal end of the sheath and an orange connector is on the proximal end of the introducer to allow the two components to be attached. The dilator is fitted with a Luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and exit holes for fluid delivery are located at the distal end of the introducer. The dilator protrudes out the distal end and allows for a gradual enlargement of the passage if needed and improves trackability along the guidewire. Once in the desired location, the dilator is removed to establish a hollow conduit for insertion of endoscopes and other instruments into and out of the urinary tract. The ReTrace Ureteral Access Sheaths are available in two diameters 10/12 Fr and 12/14 Fr. Lengths range between 28 and 55 cm. This submission is for modifications to device materials, labeling, packaging, and connector design.

The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Supris Retropubic Kit consists of the Supris implantable midurethral support sling and disposable introducers for placement using a "top-down" or "bottom-up" retropubic surgical approach. The Supris sling and introducers are indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Coloplast Altis Single Incision Sling (SIS) System includes one implantable single incision midurethral sling and two Altis introducer needles. The Altis Single Incision Sling System is provided sterile (ethylene oxide sterilization) and is for single use only. The Altis Single Incision Sling is an implantable, synthetic, knitted, low-elasticity, monofilament polypropylene, single incision midurethral sling. The mesh sling body measures approximately 7.75 cm long by 1.1cm wide. The Altis sling assembly is connected on each end to an anchor. One end of the sling assembly is connected to a short length of USP size 1 polypropylene monofilament suture connected to a static (non-tensioning) polypropylene anchor. The other end of the sling connects to a longer length of suture with a dynamic (tensioning) polypropylene/polyurethane anchor. The dynamic anchor is intended to allow intraoperative adjustment and tensioning of the sling, resulting in urethral support during instances of increased abdominal pressure, thereby preventing urine leakage. The Altis sling is non-absorbable and is intended to be permanent. The Altis introducers are helical-type instruments (one right), used to assist in the surgical placement of the Altis Single Incision Sling a transobturator technique, via a single incision vaginal approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Altis Single Incision Sling System in accordance with the Instructions for Use. The Coloplast Aris Transobturator Sling System includes an implantable midurethral sling and disposable introducer needles. The Aris sling and Aris introducers are provided sterile (ethylene oxide sterilization) and are for single use only. The Aris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Aris sling is non-absorbable and intended to be permanently implanted. Aris introducers (helical pair and flat curve) are instruments used to assist in the correct surgical placement of the Aris sling via the transobturator approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Aris sling. The Coloplast Supris Retropubic Sling System includes an implantable midurethral sling and disposable introducer needles. The Supris sling and Supris introducers are provided sterile (ethylene oxide sterilization) and are for single use only. The Supris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Supris sling is non-absorbable and intended to be permanently implanted. The Supris introducers are instruments used to assist in the correct surgical placement of the Supris sling via a retropubic approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Supris sling.

Folysil catheters are intended for use up to 30 days in adult and pediatric populations for: - Bladder drainage by urethral catheterization, - Bladder drainage by suprapubic catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL). - Bladder instillation of physiological saline solution.

Folysil catheters are thin, hollow tubes equipped with a balloon, funnel and valve, to be inserted into the bladder by the urethral or supra-pubic approach to drain urine into a urine collection bag. Folysil catheters are held in place within the bladder by the balloon, which is filled with sterile water or with aqua-glycerin solution.

The product is indicated for use on moderate to highly exuding acute and chronic wounds such as: - · Diabetic ulcers - · Leg ulcers (arterial ulcers, venous ulcers and leg ulcers of mixed etiology) - · Pressure injuries (stage 2-4) - Traumatic wounds - · Partial thickness (second degree) burns - · Donor sites - · Post-operative surgical wounds - · Exudate absorption in oncology wounds, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma

Biatain Fiber Ag is a soft, sterile, primary wound dressing made mainly from non-woven gelling carboxymethyl cellulose (CMC) fibers. In addition, non-gelling bicomponent (BiCo) fibers are incorporated to obtain strength and integrity of the products both in dry and gelled condition. Ionic silver (Ag+) is added for antimicrobial efficacy within the dressing, and ethyl lauroyl arginate (LAE) is added as combined surfactant and chelator within the dressing.

Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for adult male patients only.

Luja Coude is a single-use, sterile catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation. The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products. Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr. Luja Coudé CH/FR 18 differs from the predicate device in the catheter size variants. Luja Coudé (predicate) includes French size 8 (CH8) through French size 16 (CH16) variants compared to the subject device which is a line extension to the Luja Coudé. The reference device supports the inclusion of the 18 Fr size variant.

Silicone double loop ureteral stents: The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months. Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis: For Pyelostent® Silicone double loop ureteral stents: Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients. For Stenostent® Silicone double loop ureteral stents: Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients. The Pyelostent® and Stenostent® Silicone double loop ureteral stents may remain implanted for up to 12 months.

The ImaJin Silicone double loop ureteral stent kit product family was originally cleared as Porges™ Silicone Double Loop Ureteral Stents in 510(k) K013921. The ImaJin Silicone double loop ureteral stent family consists of three single use, autostatic stents intended to drain the upper urinary tract and allow healing in case of ureteral obstacles or damage to the ureter. The Pyelostent and Stenostent Silicone double loop ureteral stents have partial and complete reinforcement along the straight catheter section respectively to add crush resistance. The devices are provided with a pusher and in some cases a guidewire. The Silicone double loop ureteral stents are ethylene oxide sterilized, single use, implantable devices. The current submission is to update the indication for use statement, revise the Instructions for Use, add information on MRI compatibility, modify drainage hole size in some models, modify packaging, and modify the device performance specifications.