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510(k) Data Aggregation
(234 days)
The JFord Speculum Sleeve™ is a single use, inflatable vaginal wall retraction sleeve intended for use with a vaginal speculum to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
The JFord Speculum Sleeve™ is a single use, non-sterile, inflatable vaginal wall retraction sleeve designed for use with single use or reusable vaginal specula (medium or large sizes). The speculum sleeve, while used with a vaginal speculum, provides lateral displacement of vaginal tissue during routine female pelvic examinations or other gynecological procedures. The speculum sleeve is intended to assist the clinician in examination when challenged by redundant vaginal walls.
The speculum sleeve has a bottom blade pocket and top sleeve for the speculum blades and bilateral expandable pouches. Using the supplied 30 mL syringe, the expandable pouches are filled as needed with potable water or saline during use to laterally displace redundant vaginal walls to enable optimal visualization.
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