Product Code: FFZ
FDA class 2
21 CFR 876.1500
Cord, Electric, For Endoscope
Gastroenterology, Urology
The Electric Cord for Endoscope is an electrical power cable accessory that connects an endoscope or its components to a power source, enabling powered functions such as illumination or video imaging. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FFZ, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology specialty.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
33
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Basic Information
- Product Code
- FFZ
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.