Section 884.4520 - Obstetric-gynecologic general manual instrument(a)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:(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.(3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.(5) A uterine clamp is an instrument used to hold the uterus by compression.(6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina.(7) A vaginal applicator is an instrument used to insert medication into the vagina.(8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue.(9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.(b)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 .45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809 , July 25, 2001