Product Code: EYI FDA class 1 21 CFR 876.5130

Adaptor, Ureteral Catheter

Gastroenterology, Urology

The ureteral catheter adaptor is an accessory component used to connect a ureteral catheter to drainage systems, syringes, or other accessory tubing during urological procedures. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The product code is EYI, regulated under 21 CFR 876.5130 in the Gastroenterology, Urology specialty. No special regulatory flags apply.

510(k)s
0
FEI Numbers
30
Registration Numbers
30
Unique Applicants
0
Years Active

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Basic Information

Product Code
EYI
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 30 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.