FZX
19 FDA 510(k) clearances · Product code
59 daysmedian time to decision
130 days90th percentile
19clearances measured
FDA profile
- Official device name
- Guide, Surgical, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 795 · 2022: 581 · 2023: 837 · 2024: 882 · 2025: 631 · 2026: 331
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 |
|---|---|---|
| PARALLELING GUIDES (K914715) | Implant Corp. of America | 1994-02-16 |
| CIVCO STEPPER (K871413) | CIVCO Medical Instruments Co., Inc. | 1987-07-14 |
| BIOPSY NEEDLE GUIDE KIT, STERILE (K871503) | Amedic USA | 1987-07-10 |
| A.C.L. GUIDE KIT (K862564) | Aspen Laboratories, Inc. | 1986-08-18 |
| MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (K854262) | Meadox Surgimed, Inc. | 1985-12-24 |
| NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (K852402) | North American Instrument Corp. | 1985-07-11 |
| BRITISH SPINAL FUSION SET (K842698) | Downs Surgical , Ltd. | 1984-09-12 |
| THREADING TUBE (K841618) | Plastafil, Inc. | 1984-08-27 |
| DRILL GUIDE (K841619) | Plastafil, Inc. | 1984-07-11 |
| TECHMEDICA DRILL GUIDE (K841297) | Techmedica, Inc. | 1984-04-25 |
| STRAITH DRAIN INSERTER (K840835) | Surgical Technology Laboratories, Inc. | 1984-04-23 |
| ACUFEX DREZ COMMUNICATING DRILL GUIDE (K834350) | Acufex Microsurgical, Inc. | 1984-03-19 |
| GRAF MENISCAL SUTURE SET (K830720) | Acufex Microsurgical, Inc. | 1983-06-16 |
| DISPOSABLE NEEDLE HOLDERS (K821618) | Medcare Products | 1982-06-21 |
| BOUNDARY TUBING HOLDERS (K810888) | The Buckeye Cellulose Corp. | 1981-04-23 |
| SURGICAL TUBE HOLDER (K810788) | The Urology Group | 1981-04-17 |
| GABBAY-FRATER SUTURE GUIDE (K802093) | Howmedica Corp. | 1980-09-26 |
| FEEDING TUBE PLACEMENT STYLET (K792468) | Biosearch Medical Products, Inc. | 1979-12-27 |
| ENTERIC TUBE GUIDE (K790872) | Biosearch Medical Products, Inc. | 1979-05-23 |
Track FZX automatically
Every clearance here is in the API, with alerts when new ones post.