Sound, Uterine
The Uterine Sound is a thin, graduated probe used to measure the depth and direction of the uterine cavity, typically performed before IUD insertion, endometrial biopsy, or other intrauterine procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HHM, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. No special risk flags apply.
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Basic Information
- Product Code
- HHM
- Device Class
- FDA class 1
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K011840 | CERVILENZ UTERINE MEASURING SOUND | Aug 10, 2001 | Substantially Equivalent | Cervilenz, Inc. |
| K935665 | INTRAUTERINE SOUND | Feb 24, 1994 | Substantially Equivalent | Rocket of London, Ltd. |
| K884684 | ROCKET INTRAUTERINE DEPTH SOUND | Dec 20, 1988 | Substantially Equivalent | A & A Medical, Inc. |
| K883806 | ROCKET INTRAUTERINE SOUND | Oct 31, 1988 | Substantially Equivalent | A & A Medical, Inc. |
| K870550 | TEFLON UTERINE SOUND | Mar 04, 1987 | Substantially Equivalent | Cook Ob/Gyn |
| K840380 | UTERINE SOUND | Apr 30, 1984 | Substantially Equivalent | Intl. Medical Technologies, Inc. |
| K831224 | AUGROS HYSTEROMETER | Oct 28, 1983 | Substantially Equivalent | Axcan Scientific Corp. |
| K802315 | UTERINE SOUND | Jan 12, 1981 | Substantially Equivalent | Gynemetrics, Inc. |
| K781766 | UTERINE SOUND, BURNETT DISPOSABLE | Dec 07, 1978 | Substantially Equivalent | C.R. Bard, Inc. |
| K760170 | INTRAUTERINE SOUND, PLASTIC DISPOSABLE | Jul 19, 1976 | Substantially Equivalent | G.D. Searle and Co. |
FEI Numbers
This FDA classification entry is associated with 132 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 132 registration numbers. Click on an entry to view related FDA registrations.