FDA product code ESH: Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
ESH is the FDA product code for polymer, ent synthetic-pife, silicon elastomer, polyethylene, polyurethane. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under ESH. The average 510(k) review took 6 days (median 6).
Classification
| Field | Value |
|---|---|
| Device name | Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane |
| Device class | Class II |
| Regulation | 21 CFR 874.3620 |
| 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 ESH clearance
Top ESH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coe Laboratories, Inc. | 1 | 1977-08-30 |
Most recent ESH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771615 | Coe Laboratories, Inc. | AUDI-SIL EARMOLD MATERIAL | 1977-08-30 | 6 |
Recalls for ESH devices
openFDA lists no recalls for product code ESH.
Frequently asked questions
What is FDA product code ESH?
ESH is the FDA product code for polymer, ent synthetic-pife, silicon elastomer, polyethylene, polyurethane. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel.
What device class is ESH?
Class II, regulation 21 CFR 874.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code ESH?
Across 1 cleared submissions the average was 6 days from receipt to decision (median 6).
Which companies have the most ESH clearances?
Coe Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ESH
- Run a recall and safety report across every ESH manufacturer
- Watch product code ESH 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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