FDA product code EYZ: System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
EYZ is the FDA product code for system, urine drainage, closed, for nonindwelling catheter, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 14 510(k) submissions under EYZ, from 14 different applicants. The average 510(k) review took 133 days (median 132). FDA has posted 1 recall for EYZ devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top EYZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Goulter Medical, Inc. | 1 | 1997-08-11 |
| Spectrum Medsystems Corp. | 1 | 1996-11-19 |
| P.A.M., Inc. | 1 | 1995-12-12 |
| Key Medical Services, Inc. | 1 | 1995-08-04 |
| Researched, Novel Medical Devices (Rn/Md) | 1 | 1994-11-02 |
9 more applicants have EYZ clearances. See the full list in Caduvo.
Most recent EYZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964219 | Goulter Medical, Inc. | ZIP CONDOM CATHETER | 1997-08-11 | 293 |
| K961906 | Spectrum Medsystems Corp. | UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 | 1996-11-19 | 187 |
| K952780 | P.A.M., Inc. | URINARY GEL DRAINAGE SYSTEM | 1995-12-12 | 179 |
| K951597 | Key Medical Services, Inc. | URINARY DRAINAGE BAG | 1995-08-04 | 119 |
| K942753 | Researched, Novel Medical Devices (Rn/Md) | ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER | 1994-11-02 | 145 |
Recalls for EYZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-09.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code EYZ?
EYZ is the FDA product code for system, urine drainage, closed, for nonindwelling catheter, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is EYZ?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EYZ?
Across 14 cleared submissions the average was 133 days from receipt to decision (median 132).
Which companies have the most EYZ clearances?
Goulter Medical, Inc. (1); Spectrum Medsystems Corp. (1); P.A.M., Inc. (1); Key Medical Services, Inc. (1); Researched, Novel Medical Devices (Rn/Md) (1).
Have EYZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-03-09.
Next steps
- Run an FDA pathway report with predicate devices for product code EYZ
- Run a recall and safety report across every EYZ manufacturer
- Watch product code EYZ 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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