CHAKOFF ENDOSCOPY
Device Facts
| Record ID | K945421 |
|---|---|
| Device Name | CHAKOFF ENDOSCOPY |
| Applicant | Stephen Chakoff, Inc. |
| Product Code | FDG · Gastroenterology, Urology |
| Decision Date | Dec 23, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4530 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.
