FDA product code FZZ: Marker, Skin
FZZ is the FDA product code for marker, skin. It is a Class I device, regulated under 21 CFR 878.4660 and reviewed by the General and Plastic Surgery panel. FDA has cleared 23 510(k) submissions under FZZ, from 21 different applicants. The average 510(k) review took 65 days (median 52). FDA has posted 2 recalls for FZZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Marker, Skin |
| Device class | Class I |
| Regulation | 21 CFR 878.4660 |
| 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 FZZ clearance
Top FZZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Precision Dynamics Corp. | 2 | 1985-01-14 |
| Devon Industries, Inc. | 2 | 1982-06-25 |
| Surgichip, Inc. | 1 | 2004-11-09 |
| American Medical Mfg., Inc. | 1 | 1992-05-14 |
| Freckles Publications, Inc. | 1 | 1992-04-21 |
16 more applicants have FZZ clearances. See the full list in Caduvo.
Most recent FZZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042555 | Surgichip, Inc. | SURGICHIP TAG SURGICAL MARKER | 2004-11-09 | 50 |
| K915066 | American Medical Mfg., Inc. | DISPOSABLE SKIN MARKER | 1992-05-14 | 188 |
| K914759 | Freckles Publications, Inc. | BLOOM TRANSPARENT STENCIL | 1992-04-21 | 182 |
| K912730 | West Texas Lighthouse For the Blind | ROCKET SURGICAL SKIN MARKING PEN | 1991-11-07 | 140 |
| K905143 | Aesculap, Inc. | SKIN MARKER | 1991-02-06 | 83 |
Recalls for FZZ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-07-10.
Frequently asked questions
What is FDA product code FZZ?
FZZ is the FDA product code for marker, skin. It is a Class I device, regulated under 21 CFR 878.4660 and reviewed by the General and Plastic Surgery panel.
What device class is FZZ?
Class I, regulation 21 CFR 878.4660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZZ?
Across 23 cleared submissions the average was 65 days from receipt to decision (median 52).
Which companies have the most FZZ clearances?
Precision Dynamics Corp. (2); Devon Industries, Inc. (2); Surgichip, Inc. (1); American Medical Mfg., Inc. (1); Freckles Publications, Inc. (1).
Have FZZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code FZZ
- Run a recall and safety report across every FZZ manufacturer
- Watch product code FZZ 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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