Product Code: FJW FDA class 1 21 CFR 876.5540

Ring, Joint

Gastroenterology, Urology

The Joint Ring is an accessory component used in the assembly or connection of shunt systems in urological or dialysis procedures. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FJW, regulated under 21 CFR 876.5540 in the Gastroenterology and Urology specialty.

510(k)s
0
FEI Numbers
1
Registration Numbers
1
Unique Applicants
0
Years Active

Basic Information

Product Code
FJW
Device Class
FDA class 1
Regulation Number
876.5540
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 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.