FDA product code ETP: Stimulator, Caloric-Water
ETP is the FDA product code for stimulator, caloric-water. It is a Class I device, regulated under 21 CFR 874.1800 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under ETP, from 3 different applicants. The average 510(k) review took 71 days (median 45). FDA has posted 2 recalls for ETP devices.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Caloric-Water |
| Device class | Class I |
| Regulation | 21 CFR 874.1800 |
| 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 ETP clearance
Top ETP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 4 | 1986-12-16 |
| Ethicare Products | 1 | 1982-06-14 |
| Life-Tech Intl., Inc. | 1 | 1982-02-22 |
Most recent ETP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863615 | Jedmed Instrument Co. | ENTHERMO IRRIGATION UNIT | 1986-12-16 | 91 |
| K820775 | Jedmed Instrument Co. | VESTIBULARISET | 1982-11-03 | 225 |
| K821481 | Ethicare Products | NASAL-THROAT SPRAY IRRIGATION INSTRUM. | 1982-06-14 | 27 |
| K813552 | Life-Tech Intl., Inc. | MODEL 3000C CALORIC IRRIGATOR | 1982-02-22 | 63 |
| K800443 | Jedmed Instrument Co. | HYGROTHERM | 1980-03-10 | 11 |
Recalls for ETP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-12-21.
Frequently asked questions
What is FDA product code ETP?
ETP is the FDA product code for stimulator, caloric-water. It is a Class I device, regulated under 21 CFR 874.1800 and reviewed by the Ear, Nose and Throat panel.
What device class is ETP?
Class I, regulation 21 CFR 874.1800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ETP?
Across 6 cleared submissions the average was 71 days from receipt to decision (median 45).
Which companies have the most ETP clearances?
Jedmed Instrument Co. (4); Ethicare Products (1); Life-Tech Intl., Inc. (1).
Have ETP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2011-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code ETP
- Run a recall and safety report across every ETP manufacturer
- Watch product code ETP 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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