Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4530](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4530) → FDG — Retractor, Fiberoptic

# FDG · Retractor, Fiberoptic

_Gastroenterology, Urology · 21 CFR 876.4530 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG

## Overview

- **Product Code:** FDG
- **Device Name:** Retractor, Fiberoptic
- **Regulation:** [21 CFR 876.4530](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4530)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964561](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG/K964561.md) | 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](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG/K945421.md) | CHAKOFF ENDOSCOPY | Stephen Chakoff, Inc. | Dec 23, 1994 | SESE |

## Top Applicants

- Bioenterics Corp. — 1 clearance
- Stephen Chakoff, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG)

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