HXC
6 FDA 510(k) clearances · Product code
31 daysmedian time to decision
63 days90th percentile
6clearances measured
FDA profile
- Official device name
- Wrench
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 160 · 2022: 143 · 2023: 145 · 2024: 125 · 2025: 117 · 2026: 81
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 |
|---|---|---|
| Intellitorq (K180092) | Gauthier Biomedical, Inc. | 2018-03-08 |
| ADJUSTABLE WRENCHES (K874359) | Med-Tool, Inc. | 1987-11-23 |
| COMBINATION WRENCHES (K874358) | Med-Tool, Inc. | 1987-11-23 |
| TORQUEDRIVER WRENCH (K870053) | Jerome Medical | 1987-03-11 |
| SPINAL WRENCH (K813067) | Twin City Surgical, Inc. | 1981-11-24 |
| WRENCH (K791073) | Truth, Inc. | 1979-06-20 |
Track HXC automatically
Every clearance here is in the API, with alerts when new ones post.