FDA product code FZX: Guide, Surgical, Instrument
FZX is the FDA product code for guide, surgical, instrument. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 19 510(k) submissions under FZX, from 16 different applicants. The average 510(k) review took 98 days (median 59). FDA has posted 29 recalls for FZX devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Guide, Surgical, Instrument |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FZX clearance
Top FZX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Plastafil, Inc. | 2 | 1984-08-27 |
| Acufex Microsurgical, Inc. | 2 | 1984-03-19 |
| Biosearch Medical Products, Inc. | 2 | 1979-12-27 |
| Implant Corp. of America | 1 | 1994-02-16 |
| CIVCO Medical Instruments Co., Inc. | 1 | 1987-07-14 |
11 more applicants have FZX clearances. See the full list in Caduvo.
Most recent FZX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914715 | Implant Corp. of America | PARALLELING GUIDES | 1994-02-16 | 852 |
| K871413 | CIVCO Medical Instruments Co., Inc. | CIVCO STEPPER | 1987-07-14 | 97 |
| K871503 | Amedic USA | BIOPSY NEEDLE GUIDE KIT, STERILE | 1987-07-10 | 84 |
| K862564 | Aspen Laboratories, Inc. | A.C.L. GUIDE KIT | 1986-08-18 | 46 |
| K854262 | Meadox Surgimed, Inc. | MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY | 1985-12-24 | 62 |
Recalls for FZX devices
29 product recalls in 25 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2023-11-30.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code FZX?
FZX is the FDA product code for guide, surgical, instrument. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is FZX?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZX?
Across 19 cleared submissions the average was 98 days from receipt to decision (median 59).
Which companies have the most FZX clearances?
Plastafil, Inc. (2); Acufex Microsurgical, Inc. (2); Biosearch Medical Products, Inc. (2); Implant Corp. of America (1); CIVCO Medical Instruments Co., Inc. (1).
Have FZX devices been recalled?
Yes: 29 product recalls across 25 recall events; the most recent began 2023-11-30.
Next steps
- Run an FDA pathway report with predicate devices for product code FZX
- Run a recall and safety report across every FZX manufacturer
- Watch product code FZX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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