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510(k) Data Aggregation
K Number
K063079Device Name
I-STOP TRANS OBTURATOR MALE SLING
Manufacturer
CL MEDICAL
Date Cleared
2006-11-07
(28 days)
Product Code
OTM, FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
CL MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.
Device Description
I-STOP® Trans Obturator Male / Female Sling is a sterile, single use kit consisting of one sling of knitted monofilament polypropylene, two stainless two polycarbonate handles and two stainless steel needles molded with polycarbonate handles.
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K Number
K051533Device Name
I-STOP
Manufacturer
CL MEDICAL
Date Cleared
2005-08-11
(63 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
CL MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.
Device Description
I-STOP is a sterile, single use kit consisting of knitted monofilament polypropylene, two to four stainless steel needles and two polycarbonate handles. The kit is designed to be used with any of the surgical approaches to position the sling.
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