Connector, Ureteral Catheter
The ureteral catheter connector is an accessory component that joins ureteral catheters to other devices or tubing sections during urological diagnostic and therapeutic procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EYK, regulated under 21 CFR 876.5130 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- EYK
- Device Class
- FDA class 1
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934419 | URETERAL CATHETER AND ACCESSORIES | May 25, 1994 | Substantially Equivalent | Urological Associates of Central Jersey P.A. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.