Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950) → EPW — Support, Head, Surgical, Ent

# EPW · Support, Head, Surgical, Ent

_General, Plastic Surgery · 21 CFR 878.4950 · Class 1_

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

## Overview

- **Product Code:** EPW
- **Device Name:** Support, Head, Surgical, Ent
- **Regulation:** [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

## 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 § 878.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K821306](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPW/K821306.md) | HEAD-UP SUPINE SAFETY SUPPORT CUSHION | Med-Life, Inc. | Jun 7, 1982 | SESE |
| [K801326](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPW/K801326.md) | ANSPACH OPERATING TABLE SUPPORT/SPINAL | The Anspach Effort, Inc. | Jun 26, 1980 | SESE |

## Top Applicants

- Med-Life, Inc. — 1 clearance
- The Anspach Effort, Inc. — 1 clearance

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

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