FDA product code FJZ: Declotting Tray, Kit (Including Contents)
FJZ is the FDA product code for declotting tray, kit (including contents). It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FJZ, from 3 different applicants. The average 510(k) review took 40 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Declotting Tray, Kit (Including Contents) |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FJZ clearance
Top FJZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phoenix Glove Co. | 1 | 1982-06-21 |
| Megaplast, Inc. | 1 | 1982-06-21 |
| Dravon Medical, Inc. | 1 | 1977-01-06 |
Most recent FJZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821666 | Phoenix Glove Co. | STERILE SURGICAL DRAPES | 1982-06-21 | 14 |
| K821313 | Megaplast, Inc. | SURGICAL UTILITY DRAPE | 1982-06-21 | 48 |
| K760995 | Dravon Medical, Inc. | DECOLLATING TRAY | 1977-01-06 | 59 |
Recalls for FJZ devices
openFDA lists no recalls for product code FJZ.
Frequently asked questions
What is FDA product code FJZ?
FJZ is the FDA product code for declotting tray, kit (including contents). It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJZ?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJZ?
Across 3 cleared submissions the average was 40 days from receipt to decision (median 48).
Which companies have the most FJZ clearances?
Phoenix Glove Co. (1); Megaplast, Inc. (1); Dravon Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FJZ
- Run a recall and safety report across every FJZ manufacturer
- Watch product code FJZ 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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