FDA product code EYC: Catheter, Upper Urinary Tract
EYC is the FDA product code for catheter, upper urinary tract. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under EYC, from 4 different applicants. The average 510(k) review took 155 days (median 182).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Upper Urinary Tract |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EYC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 205 |
Compare with all 510(k) review times · Search every EYC clearance
Top EYC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Deroyal Industries, Inc. | 2 | 2020-10-15 |
| GE Healthcare | 1 | 2006-08-18 |
| Deroyal | 1 | 2004-07-02 |
| Kosan Far East Ent. , Ltd. | 1 | 1989-11-30 |
Most recent EYC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200757 | Deroyal Industries, Inc. | Foley Catheter with Temperature Sensor | 2020-10-15 | 205 |
| K061918 | GE Healthcare | FOLEY CATHETERS WITH TEMPERATURE PROBE | 2006-08-18 | 43 |
| K041416 | Deroyal | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | 2004-07-02 | 36 |
| K925790 | Deroyal Industries, Inc. | EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S | 1993-05-17 | 182 |
| K890310 | Kosan Far East Ent. , Ltd. | STERILE FOLEY CATHETER | 1989-11-30 | 311 |
Recalls for EYC devices
openFDA lists no recalls for product code EYC.
Frequently asked questions
What is FDA product code EYC?
EYC is the FDA product code for catheter, upper urinary tract. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is EYC?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code EYC?
Across 5 cleared submissions the average was 155 days from receipt to decision (median 182).
Which companies have the most EYC clearances?
Deroyal Industries, Inc. (2); GE Healthcare (1); Deroyal (1); Kosan Far East Ent. , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EYC
- Run a recall and safety report across every EYC manufacturer
- Watch product code EYC 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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