Retractor, Fiberoptic
The Fiberoptic Retractor (product code FDG) is a surgical retractor that incorporates fiberoptic illumination to improve visualization of the operative field during gastroenterological or urological procedures. 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 876.4530 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- FDG
- Device Class
- FDA class 1
- Regulation Number
- 876.4530
- 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.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K964561 | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA | Feb 11, 1997 | Substantially Equivalent | Bioenterics Corp. |
| K945421 | CHAKOFF ENDOSCOPY | Dec 23, 1994 | Substantially Equivalent | Stephen Chakoff, Inc. |
FEI Numbers
This FDA classification entry is associated with 77 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 77 registration numbers. Click on an entry to view related FDA registrations.