HGZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Heater, Perineal, Direct Contact
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5390
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 1993: 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 |
|---|---|---|
| E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES (K921885) | Valleylab, Inc. | 1994-03-25 |
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Every clearance here is in the API, with alerts when new ones post.