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510(k) Data Aggregation
K Number
K063136Device Name
NEEDLELESS SLING
Manufacturer
SPECIALITIES REMEEX INTERNATIONAL, S.L.
Date Cleared
2006-12-19
(64 days)
Product Code
PAH
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SPECIALITIES REMEEX INTERNATIONAL, S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NEEDLELESS SLING is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency
Device Description
The NEEDLELESS SLING is included in the sling techniques for the treatment of female stress urinary incontinence. This device is a vaginal sling that permits for the regulation of continence in the female incontinent patient. This system uses a mesh sling, placed under the urethra, that can be regulated during the intervention and just after it to achieve continence. The sling is passed through the endopelvic fascia, creating a fibrosis that supports the mid urethra as a limitation to its descending and thus providing continence.
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K Number
K062341Device Name
MALE REMEEX SYSTEM
Manufacturer
SPECIALITIES REMEEX INTERNATIONAL, S.L.
Date Cleared
2006-11-02
(84 days)
Product Code
OTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SPECIALITIES REMEEX INTERNATIONAL, S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Male Remeex System is intended to be used as a pubourethral sling for the treatment of male stress urinary incontinence
Device Description
The MALE REMEEX SYSTEM (EXternal MEchanical REqulation) is included in the sling techniques for the treatment of urinary incontinence. This system is comprised of a pubourethral sling that permits the patient continence level regulation. This system use a sling, placed under the urethra that can be regulated at any time to get the most adequate bladder neck angle for a particular patient. The sling is connected by traction threads to the prosthesis. The prosthesis is situated over the fascia of the abdominal rectus muscle and is a mechanism that permits the regulation of the sling level.
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K Number
K033310Device Name
REMEEX SYSTEM FOR URINARY INCONTINENCE
Manufacturer
SPECIALITIES REMEEX INTERNATIONAL, S.L.
Date Cleared
2004-01-15
(93 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SPECIALITIES REMEEX INTERNATIONAL, S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Remeex System is intended to be used as a pubourethral sling for treatment of female stress urinary incontinence (SUI) resulting from urethral hypomobility or hypermobility and / or intrinsic sphincter deficiency.
Device Description
The REMEEX SYSTEM (EXternal MEchanical REgulation) is included in the sling techniques for the treatment of urinary incontinence. This system is comprised of a pubourethral sling that permits the patient continence level regulation. This system use a sling, placed under the urethra that can be regulated at any time to get the most adequate bladder neck angle for a particular patient. The sling is connected by traction threads to the prosthesis. The prosthesis is situated over the fascia of the abdominal rectus muscle and is a mechanism that permits the regulation of the sling level.
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