FDA product code EYB: Catheter, Ureteral, Gastro-Urology
EYB is the FDA product code for catheter, ureteral, gastro-urology. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 28 510(k) submissions under EYB, from 21 different applicants. The average 510(k) review took 150 days (median 97). FDA has posted 4 recalls for EYB devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Ureteral, Gastro-Urology |
| 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 EYB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 258 |
| 2018 | 2 | 146 |
| 2019 | 3 | 216 |
| 2020 | 1 | 255 |
Compare with all 510(k) review times · Search every EYB clearance
Top EYB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 3 | 2019-08-05 |
| Applied Medical Resources | 3 | 1994-06-13 |
| Coloplast Corp. | 2 | 2018-10-04 |
| C.R. Bard, Inc. | 2 | 2003-11-14 |
| Cook Urological, Inc. | 2 | 1996-06-11 |
16 more applicants have EYB clearances. See the full list in Caduvo.
Most recent EYB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192183 | Promepal Sam | RocaTub Ureteral Catheter | 2020-04-23 | 255 |
| K191187 | Dornier Medtech America, Inc. | Dornier MINNOW Ureteral Catheter | 2019-09-18 | 138 |
| K183323 | Cook Incorporated | UPJ Occlusion Balloon Catheter | 2019-08-05 | 248 |
| K182695 | Cook Incorporated | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | 2019-06-17 | 263 |
| K182122 | Coloplast Corp. | Ureteric Catheters | 2018-10-04 | 59 |
Recalls for EYB devices
4 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-05-04.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code EYB?
EYB is the FDA product code for catheter, ureteral, gastro-urology. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is EYB?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code EYB?
Across 28 cleared submissions the average was 150 days from receipt to decision (median 97).
Which companies have the most EYB clearances?
Cook Incorporated (3); Applied Medical Resources (3); Coloplast Corp. (2); C.R. Bard, Inc. (2); Cook Urological, Inc. (2).
Have EYB devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2026-05-04.
Next steps
- Run an FDA pathway report with predicate devices for product code EYB
- Run a recall and safety report across every EYB manufacturer
- Watch product code EYB 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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