Lamp, Endoscope, Incandescent
An incandescent endoscope lamp is a light bulb component used in endoscopic instruments to provide illumination within body cavities during gastroenterological or urological procedures. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FTI, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FTI
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
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 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.