Light Source, Photographic, Fiberoptic
The Fiberoptic Photographic Light Source (product code FCR) is a high-intensity light source that uses fiberoptic transmission to deliver illumination for photographic documentation during endoscopic procedures. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. 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
- FCR
- Device Class
- FDA class 2
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K844774 | EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS | Apr 22, 1985 | Substantially Equivalent | Mecron Medical Products, Inc. |
| K821754 | A O FIBER OPTIC ILLUMINATOR, 1185B | Jun 24, 1982 | Substantially Equivalent | Warner-Lambert Co. |
| K821753 | A O FIBER OPTIC ILLUMINATION, 1185A | Jun 24, 1982 | Substantially Equivalent | Warner-Lambert Co. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.