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510(k) Data Aggregation
K Number
K023898Device Name
GYNE IDEAS MINITAPE RP DEVICE
Manufacturer
GYNE IDEAS LTD.
Date Cleared
2003-06-18
(208 days)
Product Code
PAH
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
GYNE IDEAS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description
The device consists of a polypropylene sling with integral serrated anchoring arms. The sling has an overall length of 14cm. It is supplied with two metal needles to aid in surgical placement of the device. The device is supplied sterile.
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