HTJ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gauge, Depth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4300
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 403 · 2022: 316 · 2023: 376 · 2024: 371 · 2025: 408 · 2026: 235
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 |
|---|---|---|
| ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE (K940480) | Acufex Microsurgical, Inc. | 1994-03-23 |
| ACUFEX INTRA ARTICULAR MEASURING DEVICE (K925335) | Acufex Microsurgical, Inc. | 1992-12-29 |
| ACROMED INTERBODY DEPTH GAUGES (K873191) | Buckman Co., Inc. | 1987-09-09 |
| RAYLOR(TM) DEPTH GAUGE (K864426) | Cedar Surgical, Inc. | 1986-11-26 |
Track HTJ automatically
Every clearance here is in the API, with alerts when new ones post.