Product Code: EYK FDA class 1 21 CFR 876.5130

Connector, Ureteral Catheter

Gastroenterology, Urology

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.

510(k)s
1
FEI Numbers
26
Registration Numbers
26
Unique Applicants
1
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K934419 URETERAL CATHETER AND ACCESSORIES

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.