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884.4530—Obstetric-gynecologic specialized manual instrument.
(a) Identification.
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:
(2)
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(5)
A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6)
A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7)
A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(10)
A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(12)
A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13)
A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14)
A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(16)
An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17)
A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18)
A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(2)
Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Code of Federal Regulations
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