HDG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Speculum, Vaginal, Metal, Fiberoptic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 1996: 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 |
|---|---|---|
| SPECULUM, VAGINAL, METAL FIBEROPTIC (K864865) | Luxtec Corp. | 1987-01-09 |
| VAGINAL ILLUMINATOR, MODEL 78570 (K771181) | Welch Allyn, Inc. | 1977-07-14 |
Track HDG automatically
Every clearance here is in the API, with alerts when new ones post.