Food and Drug Administration, HHS § 884.4550 subpart E of part 807 of this chapter, (12) A uterine sound is an instrument subject to the limitations in § 884.9. used to determine the depth of the uterus by inserting it into the uterine [45 FR 12684–12720, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July cavity. 25, 2001] (13) A cytological cervical spatula is a blunt instrument used to scrape and § 884.4530 Obstetric-gynecologic spe- remove cytological material from the cialized manual instrument. surface of the cervix or vagina. (a) Identification. An obstetric- (14) A gynecological biopsy forceps is gynecologic specialized manual instru- an instrument with two blades and ment is one of a group of devices used handles used for gynecological biopsy during obstetric-gynecologic proce- procedures. dures to perform manipulative diag- (15) A uterine tenaculum is a hook- nostic and surgical functions (e.g., di- like instrument used to seize and hold lating, grasping, measuring, and scrap- the cervix or fundus. ing), where structural integrity is the (16) An internal pelvimeter is an in- chief criterion of device performance. strument used within the vagina to This type of device consists of the fol- measure the diameter and capacity of lowing: the pelvis. (1) An amniotome is an instrument (17) A nonmetal vaginal speculum is used to rupture the fetal membranes. a nonmetal instrument used to expose (2) A circumcision clamp is an instru- the interior of the vagina. ment used to compress the foreskin of (18) A fiberoptic nonmetal vaginal the penis during circumcision of a male speculum is a nonmetal instrument, infant. with fiberoptic light, used to expose (3) An umbilical clamp is an instru- and illuminate the interior of the va- ment used to compress the umbilical gina. cord. (b) Classification. (1) Class II (per- (4) A uterine curette is an instrument formance standards). used to scrape and remove material (2) Class I for the amniotome, uterine from the uterus. curette, cervical dilator (fixed-size bou- (5) A fixed-size cervical dilator is any gies), cerclage needle, IUD remover, of a series of bougies of various sizes uterine sound, and gynecological bi- used to dilate the cervical os by opsy forceps. The devices subject to stretching the cervix. this paragraph (b)(2) are exempt from (6) A uterine elevator is an instru- the premarket notification procedures ment inserted into the uterus used to in subpart E of part 807 of this chapter, lift and manipulate the uterus. subject to the limitations in § 884.9. (7) A gynecological surgical forceps is an instrument with two blades and [45 FR 12684–12720, Feb. 26, 1980, as amended handles used to pull, grasp, or com- at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July press during gynecological examina- 25, 2001] tion. (8) A cervical cone knife is a cutting § 884.4550 Gynecologic surgical laser. instrument used to excise and remove (a) Identification. A gynecologic sur- tissue from the cervix. gical laser is a continuous wave carbon (9) A gynecological cerclage needle is dioxide laser designed to destroy tissue a looplike instrument used to suture thermally or to remove tissue by radi- the cervix. ant light energy. The device is used (10) A hook-type contraceptive intra- only in conjunction with a colposcope uterine device (IUD) remover is an in- as part of a gynecological surgical sys- strument used to remove an IUD from tem. A colposcope is a magnifying lens the uterus. system used to examine the vagina and (11) A gynecological fibroid screw is cervix. an instrument used to hold onto a fi- (b) Classification. Class II (perform- broid. ance standards). 431 VerDate Apr<18>2002 06:36 Apr 28, 2002 Jkt 197069 PO 00000 Frm 00431 Fmt 8010 Sfmt 8010 Y:\SGML\197069T.XXX pfrm12 PsN: 197069T.