FDG · Retractor, Fiberoptic
Gastroenterology, Urology · 21 CFR 876.4530 · Class 1
Overview
| Product Code | FDG |
|---|---|
| Device Name | Retractor, Fiberoptic |
| Regulation | 21 CFR 876.4530 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964561 | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA | Bioenterics Corp. | Feb 11, 1997 | SESE |
| K945421 | CHAKOFF ENDOSCOPY | Stephen Chakoff, Inc. | Dec 23, 1994 | SESE |
Top Applicants
- Stephen Chakoff, Inc. — 1 clearance
- Bioenterics Corp. — 1 clearance
