FDA product code ETC: Mold, Middle-Ear
ETC is the FDA product code for mold, middle-ear. It is a Class II device, regulated under 21 CFR 874.3430 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under ETC. The average 510(k) review took 358 days (median 358).
Classification
| Field | Value |
|---|---|
| Device name | Mold, Middle-Ear |
| Device class | Class II |
| Regulation | 21 CFR 874.3430 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| Implant | Yes |
Compare with all 510(k) review times · Search every ETC clearance
Top ETC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew Richards, Inc. | 1 | 1993-03-18 |
Most recent ETC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921433 | Smith & Nephew Richards, Inc. | ATTIC DEFECT PLATE | 1993-03-18 | 358 |
Recalls for ETC devices
openFDA lists no recalls for product code ETC.
Frequently asked questions
What is FDA product code ETC?
ETC is the FDA product code for mold, middle-ear. It is a Class II device, regulated under 21 CFR 874.3430 and reviewed by the Ear, Nose and Throat panel.
What device class is ETC?
Class II, regulation 21 CFR 874.3430. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ETC?
Across 1 cleared submissions the average was 358 days from receipt to decision (median 358).
Which companies have the most ETC clearances?
Smith & Nephew Richards, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ETC
- Run a recall and safety report across every ETC manufacturer
- Watch product code ETC 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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