HHM — Sound, Uterine Class I
FDA product code HHM covers "Sound, Uterine", a Class I medical device regulated under 21 CFR 884.4530. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HHM
- Device Class
- Class I
- Regulation Number
- 884.4530
- Submission Type
- 510(k) Exempt
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K011840 | Cervilenz | CERVILENZ UTERINE MEASURING SOUND | Aug 10, 2001 |
| K935665 | Rocket Of London | INTRAUTERINE SOUND | Feb 24, 1994 |
| K884684 | A And A Medical | ROCKET INTRAUTERINE DEPTH SOUND | Dec 20, 1988 |
| K883806 | A And A Medical | ROCKET INTRAUTERINE SOUND | Oct 31, 1988 |
| K870550 | Cook Ob/Gyn | TEFLON UTERINE SOUND | Mar 4, 1987 |
| K840380 | Intl. Medical Technologies | UTERINE SOUND | Apr 30, 1984 |
| K831224 | Axcan Scientific | AUGROS HYSTEROMETER | Oct 28, 1983 |
| K802315 | Gynemetrics | UTERINE SOUND | Jan 12, 1981 |
| K781766 | C.R. Bard | UTERINE SOUND, BURNETT DISPOSABLE | Dec 7, 1978 |
| K760170 | G.D. Searle And | INTRAUTERINE SOUND, PLASTIC DISPOSABLE | Jul 19, 1976 |