FDA product code EYY: Drape, Urological, Disposable
EYY is the FDA product code for drape, urological, disposable. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under EYY, from 2 different applicants. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Drape, Urological, Disposable |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EYY clearance
Top EYY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lingeman Medical Products, Inc. | 1 | 1985-05-14 |
| Unimar, Inc. | 1 | 1981-03-18 |
Most recent EYY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851675 | Lingeman Medical Products, Inc. | THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE | 1985-05-14 | 21 |
| K810291 | Unimar, Inc. | STERILE/DISPOSABLE HSG TRAY | 1981-03-18 | 43 |
Recalls for EYY devices
openFDA lists no recalls for product code EYY.
Frequently asked questions
What is FDA product code EYY?
EYY is the FDA product code for drape, urological, disposable. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.
What device class is EYY?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EYY?
Across 2 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most EYY clearances?
Lingeman Medical Products, Inc. (1); Unimar, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EYY
- Run a recall and safety report across every EYY manufacturer
- Watch product code EYY 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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