HHM · Sound, Uterine
Obstetrics/Gynecology · 21 CFR 884.4530 · Class 1
Overview
| Product Code | HHM |
|---|---|
| Device Name | Sound, Uterine |
| Regulation | 21 CFR 884.4530 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
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:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (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. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (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. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (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.
Classification Rationale
(1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(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.
Special Controls
*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(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.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011840 | CERVILENZ UTERINE MEASURING SOUND | Cervilenz, Inc. | Aug 10, 2001 | SESE |
| K935665 | INTRAUTERINE SOUND | Rocket of London, Ltd. | Feb 24, 1994 | SESE |
| K884684 | ROCKET INTRAUTERINE DEPTH SOUND | A & A Medical, Inc. | Dec 20, 1988 | SESE |
| K883806 | ROCKET INTRAUTERINE SOUND | A & A Medical, Inc. | Oct 31, 1988 | SESE |
| K870550 | TEFLON UTERINE SOUND | Cook Ob/Gyn | Mar 4, 1987 | SESE |
| K840380 | UTERINE SOUND | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE |
| K831224 | AUGROS HYSTEROMETER | Axcan Scientific Corp. | Oct 28, 1983 | SESE |
| K802315 | UTERINE SOUND | Gynemetrics, Inc. | Jan 12, 1981 | SESE |
| K781766 | UTERINE SOUND, BURNETT DISPOSABLE | C.R. Bard, Inc. | Dec 7, 1978 | SESE |
| K760170 | INTRAUTERINE SOUND, PLASTIC DISPOSABLE | G.D. Searle and Co. | Jul 19, 1976 | SESE |
Top Applicants
- A & A Medical, Inc. — 2 clearances
- Rocket of London, Ltd. — 1 clearance
- Intl. Medical Technologies, Inc. — 1 clearance
- Gynemetrics, Inc. — 1 clearance
- G.D. Searle and Co. — 1 clearance
