Attachment, Eyepiece, For Insertion Of Prescription Lens
The Eyepiece Attachment for Insertion of Prescription Lens (product code FDZ) is an accessory that fits onto the eyepiece of an endoscope to accommodate a clinician's prescription corrective lens, enabling comfortable visualization without external eyewear. 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.
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Basic Information
- Product Code
- FDZ
- Device Class
- FDA class 1
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
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 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.