Identification. An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:
An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.
A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.
An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.
A uterine clamp is an instrument used to hold the uterus by compression.
A uterine packer is an instrument used to introduce dressing into the uterus or vagina.
A vaginal applicator is an instrument used to insert medication into the vagina.
A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue.
A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.
A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.
Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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