FDA product code ESF: Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
ESF is the FDA product code for polymer, composite synthetic ptfe with carbon-fiber, ent. It is a Class II device, regulated under 21 CFR 878.3500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under ESF, from 2 different applicants. The average 510(k) review took 92 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent |
| Device class | Class II |
| Regulation | 21 CFR 878.3500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every ESF clearance
Top ESF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Hearing Instruments, Inc. | 1 | 1989-03-29 |
| Xomed, Inc. | 1 | 1982-04-21 |
Most recent ESF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891247 | Siemens Hearing Instruments, Inc. | BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC | 1989-03-29 | 21 |
| K813224 | Xomed, Inc. | CERAVITAL CERAMIC EAR CANAL WALL PROSTH | 1982-04-21 | 163 |
Recalls for ESF devices
openFDA lists no recalls for product code ESF.
Frequently asked questions
What is FDA product code ESF?
ESF is the FDA product code for polymer, composite synthetic ptfe with carbon-fiber, ent. It is a Class II device, regulated under 21 CFR 878.3500 and reviewed by the General and Plastic Surgery panel.
What device class is ESF?
Class II, regulation 21 CFR 878.3500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ESF?
Across 2 cleared submissions the average was 92 days from receipt to decision (median 92).
Which companies have the most ESF clearances?
Siemens Hearing Instruments, Inc. (1); Xomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ESF
- Run a recall and safety report across every ESF manufacturer
- Watch product code ESF 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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