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
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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
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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.