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510(k) Data Aggregation
K Number
K130046Device Name
CLEARSPEC SINGLE USE VAGINAL SPECULUM
Manufacturer
CLEARSPEC LLC
Date Cleared
2013-08-06
(210 days)
Product Code
HIB
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
CLEARSPEC LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearSpec Single-Use Vaginal Speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
Device Description
The ClearSpec Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, used to dilate the vagina and expose the interior of the vagina and exterior of the cervix, and employs a unique flexible polyurethane sheath that is designed to assist in keeping the lateral walls of the vagina clear of the viewing area. The vaginal speculum can be used with or without an illuminator. The ClearSpec® Single Use Vaginal Speculum is made available in various sizes from extra small to large to accommodate vagina cavity size.
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