FDA product code FZO: Chisel, Surgical, Manual
FZO is the FDA product code for chisel, surgical, manual. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under FZO, from 2 different applicants. The average 510(k) review took 62 days (median 62). FDA has posted 1 recall for FZO devices.
Classification
| Field | Value |
|---|---|
| Device name | Chisel, Surgical, Manual |
| 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 FZO clearance
Top FZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-06-20 |
| Imm Enterprises , Ltd. | 1 | 1984-01-27 |
Most recent FZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851788 | Artiberia | 29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES, | 1985-06-20 | 56 |
| K834198 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #12 40/41 | 1984-01-27 | 67 |
Recalls for FZO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-06-24.
Frequently asked questions
What is FDA product code FZO?
FZO is the FDA product code for chisel, surgical, manual. 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 FZO?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZO?
Across 2 cleared submissions the average was 62 days from receipt to decision (median 62).
Which companies have the most FZO clearances?
Artiberia (1); Imm Enterprises , Ltd. (1).
Have FZO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code FZO
- Run a recall and safety report across every FZO manufacturer
- Watch product code FZO 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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