FDA product code FZQ: Clip, Removable (Skin)
FZQ is the FDA product code for clip, removable (skin). It is a Class I device, regulated under 21 CFR 878.4320 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under FZQ, from 6 different applicants. The average 510(k) review took 37 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Clip, Removable (Skin) |
| Device class | Class I |
| Regulation | 21 CFR 878.4320 |
| 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 FZQ clearance
Top FZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alto Development Corp. | 1 | 1988-11-30 |
| Beiersdorf, Inc. | 1 | 1987-09-30 |
| Surgeons Choice, Inc. | 1 | 1983-04-12 |
| Acme United Corp. | 1 | 1983-04-12 |
| Temp-Stik Corp. | 1 | 1982-11-08 |
1 more applicants have FZQ clearances. See the full list in Caduvo.
Most recent FZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884783 | Alto Development Corp. | RANEY CLIP | 1988-11-30 | 15 |
| K873744 | Beiersdorf, Inc. | LEUKOCLIP(R) | 1987-09-30 | 14 |
| K830704 | Acme United Corp. | ONE TIME DISPOSABLE SKIN STAPLER | 1983-04-12 | 36 |
| K830768 | Surgeons Choice, Inc. | DISPOSABLE SKIN STAPLER | 1983-04-12 | 32 |
| K822963 | Temp-Stik Corp. | SURGICAL PRODUCTS, SKIN STAPLE REMOVER | 1982-11-08 | 34 |
Recalls for FZQ devices
openFDA lists no recalls for product code FZQ.
Frequently asked questions
What is FDA product code FZQ?
FZQ is the FDA product code for clip, removable (skin). It is a Class I device, regulated under 21 CFR 878.4320 and reviewed by the General and Plastic Surgery panel.
What device class is FZQ?
Class I, regulation 21 CFR 878.4320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZQ?
Across 6 cleared submissions the average was 37 days from receipt to decision (median 33).
Which companies have the most FZQ clearances?
Alto Development Corp. (1); Beiersdorf, Inc. (1); Surgeons Choice, Inc. (1); Acme United Corp. (1); Temp-Stik Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FZQ
- Run a recall and safety report across every FZQ manufacturer
- Watch product code FZQ 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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