Product Code: FCP
FDA class 1
21 CFR 876.1500
Box, Battery, Pocket
Gastroenterology, Urology
The Pocket Battery Box (product code FCP) is a compact, portable battery unit designed to supply power to endoscopic or urological instruments in a pocket-sized form factor. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.
510(k)s
2
FEI Numbers
2
Registration Numbers
2
Unique Applicants
2
Years Active
2
Basic Information
- Product Code
- FCP
- Device Class
- FDA class 1
- Regulation Number
- 876.1500
- 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
Loading...
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.