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510(k) Data Aggregation
K Number
K182144Device Name
Bi-Flex Evo
Manufacturer
Date Cleared
2018-09-07
(30 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Promepla Sam
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BiFlex Evo is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
Device Description
The Bi-Flex Evo Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes,10/12 and 12/14 FR, and two lengths, 35 and 45 cm.
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K Number
K173734Device Name
RocaJJ Soft Stents
Manufacturer
Date Cleared
2018-03-12
(96 days)
Product Code
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
Promepla SAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Roca.IJ Soft Stents are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic techniques.
The stents are not intended as a permanent indwelling devices, it is recommended that:
- The indwelling time not exceed 6 days when the device is used with the removal string;
- The indwelling time not exceed 365 days when the device is used without the removal string.
Device Description
The RocaJJ Soft Stents system is a set consisting of a tubular double pigtail stent made up of flexible radiopaque polyurethane, with a polypropylene-monofilament suture loop in order to facilitate the extraction of the ureteral stent.
The devices may include a pusher with a radiopaque tip, and a guidewire. Otherwise, these sets may include only a pusher.
The RocaJJ Soft Stents are from 4.8 to 8.0 Fr in diameter and from 24 to 30 cm in specified length.
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K Number
K152278Device Name
ENDOFLOW II - Irrigation, Warming and Suction System
Manufacturer
Date Cleared
2016-02-09
(181 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PROMEPLA SAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.
Device Description
The ENDOFLOW® II System includes the electro medical device and a full range of disposables dedicated to perform endoscopic procedures for Endo-urology, Hysteroscopy and Laparoscopy surgerv. The ENDOFLOW® II System is a complete fluid management system permitting, all-in-one, the control of the Irrigation, the temperature of the fluid and the suction. The ENDOFLOW® II permits a continuous and non-pulsating liquid flow to inflate and clean the surgical field and to improve the surgeon's visibility. With the ENDOFLOW® II system, the indicated pressure on the machine is identical to the pressure in the cavity. The ENDOFLOW® II heats and maintains the fluid bag at 38°C during the entire procedure. The user can disable this function. The ENDOFLOW® II, in its double chamber version, MEN02PUS, offers an aspiration system that can be activated with the touch screen and/or a footswitch.
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K Number
K140441Device Name
BI-FLEX URETERAL ACCESS SHEATH
Manufacturer
Date Cleared
2014-06-17
(116 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
PROMEPLA SAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bi-Flex Ureteral Access Sheath is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
Device Description
The Bi-Flex Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR, and two lengths, 35 and 45 cm.
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K Number
K120160Device Name
ROCAMED ROCAUS PLATINUM
Manufacturer
Date Cleared
2012-05-14
(116 days)
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
PROMEPLA SAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
Device Description
The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.
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K Number
K071421Device Name
PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
Manufacturer
Date Cleared
2007-10-04
(135 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
PROMEPLA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only.
Device Description
The Promepla Intravascular administration and extension sets contain components that are commonly found in this category of IV sets. The IV Administration (pump tube) Set belongs to a full line of intravenous fluid delivery sets. It is an infusion set intended to deliver fluids, medications, blood and blood products, using continuous or intermittent delivery through clinically acceptable routes of administration (e.g. intravenous, intra-arterial, subcutaneous, epidural, enteral or irrigation of fluid spaces). An optional component, a flow controller allows the use with a peristaltic pump. The Extension Set device is a triple lumen peripheral set with two detachable long lines, belonging to a family of extension tubing sets. This device uses a main gravity drip line, plus the two long extension limbs. It is a connector system, which has anti free-flow valves and line clamps, which are common in intravascular extension sets on the market. The extension set allows IV fluids to be given simultaneously by way of the same connector. Both the IV Administration Set and Extension Set are provided sterile (by Eto) and are for single use only. They are intended only for use by trained professionals in a clinic or hospital environment.
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