Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4560](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4560) → EYS — Ribdam

# EYS · Ribdam

_Gastroenterology, Urology · 21 CFR 876.4560 · Class 1_

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

## Overview

- **Product Code:** EYS
- **Device Name:** Ribdam
- **Regulation:** [21 CFR 876.4560](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4560)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

A ribdam is a device that consists of a broad strip of latex with supporting ribs used to drain surgical wounds where copious urine drainage is expected.

## 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 (0 of 0)

_No cleared devices on record._

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

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