FDA product code FDZ: Attachment, Eyepiece, For Insertion Of Prescription Lens
FDZ is the FDA product code for attachment, eyepiece, for insertion of prescription lens. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FDZ, from 2 different applicants. The average 510(k) review took 176 days (median 176).
Classification
| Field | Value |
|---|---|
| Device name | Attachment, Eyepiece, For Insertion Of Prescription Lens |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FDZ clearance
Top FDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exel Intl. | 1 | 1990-02-16 |
| Teleflexmedical, Inc. | 1 | 1986-01-16 |
Most recent FDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895772 | Exel Intl. | EXEL INDWELLING CATHETER | 1990-02-16 | 143 |
| K852642 | Teleflexmedical, Inc. | CENTRAL VEIN CATHETERIZATION TRAY | 1986-01-16 | 209 |
Recalls for FDZ devices
openFDA lists no recalls for product code FDZ.
Frequently asked questions
What is FDA product code FDZ?
FDZ is the FDA product code for attachment, eyepiece, for insertion of prescription lens. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FDZ?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FDZ?
Across 2 cleared submissions the average was 176 days from receipt to decision (median 176).
Which companies have the most FDZ clearances?
Exel Intl. (1); Teleflexmedical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FDZ
- Run a recall and safety report across every FDZ manufacturer
- Watch product code FDZ 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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