Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4890](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4890) → EYD — Stirrups

# EYD · Stirrups

_Gastroenterology, Urology · 21 CFR 876.4890 · Class 1_

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

## Overview

- **Product Code:** EYD
- **Device Name:** Stirrups
- **Regulation:** [21 CFR 876.4890](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4890)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.

## Classification Rationale

(1) Class II (special controls) for the electrically powered urological table and accessories. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Special Controls

*Classification.* (1) Class II (special controls) for the electrically powered urological table and accessories. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) 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/EYD](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EYD)

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