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510(k) Data Aggregation
K Number
K181346Device Name
CystoSure Plus Catheter
Manufacturer
Date Cleared
2018-08-06
(77 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Emmy Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CystoSure® Plus catheter provides access and visualization for the female urinary bladder.
The single-use CystoSure® Plus catheter provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of an endoscope. It is suitable for medium- to long-term use with a maximum patient indwelling time < 30 days.
Device Description
The CystoSure® and CystoSure® Plus catheters are intended for use in the diagnostic visualization of the female bladder with a port to allow for the insertion of an endoscope. They are made from silicone and they are used in both surgical and diagnostic procedures for draining the bladder and enabling the visualization of internal bladder surfaces.
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K Number
K142194Device Name
CytoSure Urinary Access System
Manufacturer
Date Cleared
2014-12-19
(130 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Emmy Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CystoSure™ Urinary Access System provides catheterization and visualization for the female urinary bladder.
The CystoSure™ rigid metal scope is used to visualize the urinary bladder for diagnostic procedures. The CystoSure™ access catheter accessory provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of the CystoSure™ scope.
Device Description
The Emmy Medical CystoSure Urinary Access System is intended for use in the diagnostic visualization of the female bladder. The CystoSure cystoscope is a reusable, rod lens optic that can be used with standard O.R. camera couplers and light guides. The length and field of view of the Emmy Medical cystoscope are optimized for inspection of the female bladder. The Emmy Medical cystoscope does not include the traditional outer sheath as those functions are provided by the access catheter accessory.
The CystoSure Access Catheter accessory provides a single use access catheter with four ports: One for bladder drainage, one for bladder irrigation, one for balloon inflation and one for the CystoSure cystoscope. The access catheter encompasses only one balloon size (5 cc) and length (female only) and it does not include any hydrophilic or antimicrobial coatings or features to make it radiopaque.
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