Catheter, Upper Urinary Tract
The upper urinary tract catheter is a tubular device introduced through the lower urinary tract to access the ureters or renal collecting system for diagnostic imaging, urine sampling, or therapeutic drainage. It is classified as FDA Class 2, representing moderate risk, and requires 510(k) premarket clearance. The product code is EYC, regulated under 21 CFR 876.5130 in the Gastroenterology, Urology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- EYC
- Device Class
- FDA class 2
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K200757 | Foley Catheter with Temperature Sensor | Oct 15, 2020 | Substantially Equivalent | Deroyal Industries, Inc. |
| K061918 | FOLEY CATHETERS WITH TEMPERATURE PROBE | Aug 18, 2006 | Substantially Equivalent | GE Healthcare |
| K041416 | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | Jul 02, 2004 | Substantially Equivalent | Deroyal |
| K925790 | EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S | May 17, 1993 | Substantially Equivalent | Deroyal Industries, Inc. |
| K890310 | STERILE FOLEY CATHETER | Nov 30, 1989 | Substantially Equivalent | Kosan Far East Ent. , Ltd. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.