← Product Code [FDG](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG) · K945421

# CHAKOFF ENDOSCOPY (K945421)

_Stephen Chakoff, Inc. · FDG · Dec 23, 1994 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG/K945421

## Device Facts

- **Applicant:** Stephen Chakoff, Inc.
- **Product Code:** [FDG](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG.md)
- **Decision Date:** Dec 23, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4530
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG/K945421](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDG/K945421)

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