FDA product code EYR: Tourniquet, Gastro-Urology
EYR is the FDA product code for tourniquet, gastro-urology. It is a Class I device, regulated under 21 CFR 878.5900 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under EYR, from 2 different applicants. The average 510(k) review took 44 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Tourniquet, Gastro-Urology |
| Device class | Class I |
| Regulation | 21 CFR 878.5900 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EYR clearance
Top EYR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tecnol New Jersey Wound Care, Inc. | 1 | 1981-01-13 |
| Keithley Development Co. | 1 | 1979-12-06 |
Most recent EYR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802850 | Tecnol New Jersey Wound Care, Inc. | TECNOL O.R. TOURNIQUET COVER | 1981-01-13 | 62 |
| K792256 | Keithley Development Co. | KEITHLEY CLAMP | 1979-12-06 | 27 |
Recalls for EYR devices
openFDA lists no recalls for product code EYR.
Frequently asked questions
What is FDA product code EYR?
EYR is the FDA product code for tourniquet, gastro-urology. It is a Class I device, regulated under 21 CFR 878.5900 and reviewed by the General and Plastic Surgery panel.
What device class is EYR?
Class I, regulation 21 CFR 878.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EYR?
Across 2 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most EYR clearances?
Tecnol New Jersey Wound Care, Inc. (1); Keithley Development Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EYR
- Run a recall and safety report across every EYR manufacturer
- Watch product code EYR 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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