FDA product code ESX: Tack, Sacculotomy (Cody Tack)
ESX is the FDA product code for tack, sacculotomy (cody tack). It is a Class II device, regulated under 21 CFR 874.3760 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under ESX. The average 510(k) review took 114 days (median 114).
Classification
| Field | Value |
|---|---|
| Device name | Tack, Sacculotomy (Cody Tack) |
| Device class | Class II |
| Regulation | 21 CFR 874.3760 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every ESX clearance
Top ESX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micromedics, Inc. | 1 | 1983-10-19 |
Most recent ESX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832068 | Micromedics, Inc. | CODY SACCULOTOMY TACK | 1983-10-19 | 114 |
Recalls for ESX devices
openFDA lists no recalls for product code ESX.
Frequently asked questions
What is FDA product code ESX?
ESX is the FDA product code for tack, sacculotomy (cody tack). It is a Class II device, regulated under 21 CFR 874.3760 and reviewed by the Ear, Nose and Throat panel.
What device class is ESX?
Class II, regulation 21 CFR 874.3760. Typical premarket route: 510(k).
How long does a 510(k) take for product code ESX?
Across 1 cleared submissions the average was 114 days from receipt to decision (median 114).
Which companies have the most ESX clearances?
Micromedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ESX
- Run a recall and safety report across every ESX manufacturer
- Watch product code ESX 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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