HDP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Elevator, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1996: 1 · 2006: 2
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 |
|---|---|---|
| SINGLE CHANNEL BALLOON CANNULA (K974801) | Conkin Surgical Instruments , Ltd. | 1998-07-09 |
| COLPO CUP CVC-2000 (K974563) | Clinical Innovations, Inc. | 1998-03-02 |
| HYSTERO KIT (K882054) | Zinnanti Surgical Instruments, Inc. | 1988-09-29 |
| HASSON BUEC-3 (K820672) | Bivona Medical Technologies | 1982-07-30 |
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Every clearance here is in the API, with alerts when new ones post.