FDA product code JZD: Snare, Ear
JZD is the FDA product code for snare, ear. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under JZD, from 2 different applicants. The average 510(k) review took 44 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Snare, Ear |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZD clearance
Top JZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Canberra Industries, Inc. | 1 | 1983-12-29 |
| Kelleher Corp. | 1 | 1982-08-25 |
Most recent JZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834168 | Canberra Industries, Inc. | FIBRINOGEN UPTAKE SYS -VARIOUS MODELS | 1983-12-29 | 55 |
| K822199 | Kelleher Corp. | EAR SNARES | 1982-08-25 | 33 |
Recalls for JZD devices
openFDA lists no recalls for product code JZD.
Frequently asked questions
What is FDA product code JZD?
JZD is the FDA product code for snare, ear. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is JZD?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZD?
Across 2 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most JZD clearances?
Canberra Industries, Inc. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZD
- Run a recall and safety report across every JZD manufacturer
- Watch product code JZD 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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