HIC
5 FDA 510(k) clearances · Product code
90 daysmedian time to decision
787 days90th percentile
5clearances measured
FDA profile
- Official device name
- Speculum, Vaginal, Nonmetal, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- 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 |
|---|---|---|
| PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY (K955790) | Trylon Corp. | 1996-03-21 |
| LIGHTING SOURCE SYSTEM (K923656) | Galenica Enterprises, Inc. | 1994-09-08 |
| NEW LENGTH SUGITA APPLIERS (K902516) | Sims Surgical, Inc. | 1990-07-03 |
| CENTURION VAGINAL SPECULUM (K897100) | Tri-State Hospital Supply Corp. | 1990-03-16 |
| SPECULITE DISPOSABLE VAGINAL LIGHT (K853257) | Trylon Associates, Ltd. | 1985-12-27 |
Track HIC automatically
Every clearance here is in the API, with alerts when new ones post.