FDA product code JZB: Scissors, Ear
JZB is the FDA product code for scissors, 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 4 510(k) submissions under JZB, from 4 different applicants. The average 510(k) review took 46 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Scissors, 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 JZB clearance
Top JZB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1991-11-19 |
| Treace Medical, Inc. | 1 | 1987-03-03 |
| Microtek Medical, Inc. | 1 | 1984-01-03 |
| Kelleher Corp. | 1 | 1982-08-30 |
Most recent JZB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914226 | E.I. Dupont DE Nemours & Co., Inc. | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | 1991-11-19 | 60 |
| K870756 | Treace Medical, Inc. | VEIN GRAFT EAR SCISSORS | 1987-03-03 | 5 |
| K833603 | Microtek Medical, Inc. | SCISSORS SHEA BELLUCC | 1984-01-03 | 83 |
| K822196 | Kelleher Corp. | EAR SCISSORS | 1982-08-30 | 38 |
Recalls for JZB devices
openFDA lists no recalls for product code JZB.
Frequently asked questions
What is FDA product code JZB?
JZB is the FDA product code for scissors, 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 JZB?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZB?
Across 4 cleared submissions the average was 46 days from receipt to decision (median 49).
Which companies have the most JZB clearances?
E.I. Dupont DE Nemours & Co., Inc. (1); Treace Medical, Inc. (1); Microtek Medical, Inc. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZB
- Run a recall and safety report across every JZB manufacturer
- Watch product code JZB 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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