21 CFR §884.4520

1. (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. (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. (2)A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
   3. (3)A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.
   4. (4)An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.
   5. (5)A uterine clamp is an instrument used to hold the uterus by compression.
   6. (6)A uterine packer is an instrument used to introduce dressing into the uterus or vagina.
   7. (7)A vaginal applicator is an instrument used to insert medication into the vagina.
   8. (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. (9)A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.
   10. (10)A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.
2. (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.