Product Code: EYJ FDA class 1 21 CFR 876.5130

Holder, Ureteral Catheter

Gastroenterology, Urology

The ureteral catheter holder is a device used to stabilize and secure a ureteral catheter in position during cystoscopic procedures, preventing inadvertent displacement of the catheter during instrumentation. It is classified as FDA Class 1, indicating minimal risk, subject only to general controls. The product code is EYJ, regulated under 21 CFR 876.5130 in the Gastroenterology, Urology specialty. No special regulatory flags apply.

510(k)s
0
FEI Numbers
77
Registration Numbers
77
Unique Applicants
0
Years Active

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Basic Information

Product Code
EYJ
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

FEI Numbers

This FDA classification entry is associated with 77 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 77 registration numbers. Click on an entry to view related FDA registrations.