Instrument, Special Lens, For Endoscope
The Special Lens Instrument for Endoscope is an optical accessory used in conjunction with endoscopic equipment to provide specialized viewing capabilities during gastrointestinal and urological procedures. It is classified as FDA Class 1, the lowest risk category, meaning it is subject only to general controls such as proper labeling and manufacturing standards. The product code is FEI, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FEI
- 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 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.