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510(k) Data Aggregation
K Number
K052420Device Name
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
Manufacturer
Date Cleared
2006-04-06
(216 days)
Product Code
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
GYNOVA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.
Device Description
G-SpecTM Articulated Weighted Vaginal Speculum is supplied with single use disposable blades that attached to a 2 pound stainless steel weighted speculum handle. The disposable blades are supplied in three sizes: 9, 11, and 13 centimeters And can be set to three positions relative to the weighted handle: 90, 80, and 70 degrees The disposable blades snap fit into the reusable weighted speculum handle and are discarded after each use. The reusable weighted speculum handle is reusable and may be cleaned and resterilized.
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