Product code EYC
- Device name
- Catheter, Upper Urinary Tract
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200757 | Foley Catheter with Temperature Sensor | Deroyal Industries, Inc. | 2020-10-15 |
| K061918 | FOLEY CATHETERS WITH TEMPERATURE PROBE | GE Healthcare | 2006-08-18 |
| K041416 | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | Deroyal | 2004-07-02 |
| K925790 | EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S | Deroyal Industries, Inc. | 1993-05-17 |
| K890310 | STERILE FOLEY CATHETER | Kosan Far East Ent. , Ltd. | 1989-11-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00749756399296 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2025-07-23 |
| 50749756399277 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2025-07-23 |
| 00749756399289 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2025-07-23 |
| 00749756399272 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2025-07-23 |
| 00749756984010 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-05-07 |
| 00749756984003 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-05-07 |
| 00749756983990 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-05-07 |
| 10885403251320 | N/A | Carefusion Finland 320 Oy | 2016-09-14 |
| 10885403251658 | N/A | Carefusion Finland 320 Oy | 2016-09-14 |
| 10885403251313 | N/A | Carefusion Finland 320 Oy | 2016-09-14 |
| 00749756596664 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756824538 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756712316 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756712309 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756712293 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756712286 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756712279 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756712262 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756596671 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756045759 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756596657 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756045742 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756140133 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756140126 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756140119 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756045803 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756045797 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756045780 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756045773 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756045766 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |