HWQ
9 FDA 510(k) clearances · Product code
42 daysmedian time to decision
449 days90th percentile
9clearances measured
FDA profile
- Official device name
- Passer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 160 · 2022: 63 · 2023: 60 · 2024: 50 · 2025: 68 · 2026: 24
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 |
|---|---|---|
| MITEK SUTURE RETROGRADER (K970360) | Mitek Products | 1997-03-10 |
| SOFT TISSUE EXPANDER (K923381) | Acufex Microsurgical, Inc. | 1993-05-05 |
| ACUFEX PASSING PINS AND SURGICAL WIRE (K920621) | Acufex Microsurgical, Inc. | 1993-05-05 |
| MENISCUS MENDER II LOOP (K885311) | Instrument Makar, Inc. | 1989-02-09 |
| VICO MICRO SURGICAL INSTRUMENTS (K843592) | Visitec Co. | 1984-10-05 |
| SOFT-TISSUE INSTRUMENT (K841622) | Plastafil, Inc. | 1984-07-11 |
| SLOTTED SOFT-TISSUE INSTRUMENT (K841623) | Plastafil, Inc. | 1984-07-11 |
| SILASTIC TENDON PASSER H.P. (K811679) | Dow Corning Corp. Healthcare Industries Materials | 1981-07-10 |
| ROTH-KENNEDY PASSER (K791960) | 3M Company | 1979-10-04 |
Track HWQ automatically
Every clearance here is in the API, with alerts when new ones post.