HHO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Screw, Fibroid, Gynecological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 1995: 1 · 1997: 1
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 |
|---|---|---|
| HYSTEROSCOPIC MYOMA SCREW (K915412) | Cook Urological, Inc. | 1992-05-18 |
| LAPAROCOPIC MYOMA SCREW (K915388) | Cook Urological, Inc. | 1992-05-18 |
Track HHO automatically
Every clearance here is in the API, with alerts when new ones post.