HHM
10 FDA 510(k) clearances · Product code
59 daysmedian time to decision
196 days90th percentile
10clearances measured
FDA profile
- Official device name
- Sound, Uterine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 2010: 11 · 2011: 21 · 2012: 10 · 2013: 8 · 2014: 7 · 2016: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CERVILENZ UTERINE MEASURING SOUND (K011840) | Cervilenz, Inc. | 2001-08-10 |
| INTRAUTERINE SOUND (K935665) | Rocket of London, Ltd. | 1994-02-24 |
| ROCKET INTRAUTERINE DEPTH SOUND (K884684) | A & A Medical, Inc. | 1988-12-20 |
| ROCKET INTRAUTERINE SOUND (K883806) | A & A Medical, Inc. | 1988-10-31 |
| TEFLON UTERINE SOUND (K870550) | Cook Ob/Gyn | 1987-03-04 |
| UTERINE SOUND (K840380) | Intl. Medical Technologies, Inc. | 1984-04-30 |
| AUGROS HYSTEROMETER (K831224) | Axcan Scientific Corp. | 1983-10-28 |
| UTERINE SOUND (K802315) | Gynemetrics, Inc. | 1981-01-12 |
| UTERINE SOUND, BURNETT DISPOSABLE (K781766) | C.R. Bard, Inc. | 1978-12-07 |
| INTRAUTERINE SOUND, PLASTIC DISPOSABLE (K760170) | G.D. Searle and Co. | 1976-07-19 |
Track HHM automatically
Every clearance here is in the API, with alerts when new ones post.