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) → FSE — Table, Operating-Room, Manual

# FSE · Table, Operating-Room, Manual

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

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

## Overview

- **Product Code:** FSE
- **Device Name:** Table, Operating-Room, Manual
- **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 (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K860503](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K860503.md) | THE POREX RETRACTOR TABLE | Porex Medical | Mar 13, 1986 | SESE |
| [K843801](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K843801.md) | MASON EQUIPMENT ORGANIZER & ASPEN | Aspen Laboratories, Inc. | Oct 25, 1984 | SESE |
| [K840027](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K840027.md) | OPERATING ROOM STAND | Healthmate, Inc. | Feb 4, 1984 | SESE |
| [K831042](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K831042.md) | CHEMONUCLEOLYSIS TABLE EXTENSION | Orthopedic Systems, Inc. | May 16, 1983 | SESE |
| [K830339](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K830339.md) | IMSI/METRIPOND HAND OPERATING TABLE | Intl. Management Services, Inc. | Apr 12, 1983 | SESE |
| [K822427](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K822427.md) | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | Surgi-Quip Inc.U | Sep 14, 1982 | SESE |
| [K821924](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K821924.md) | TABLE, OPERATING, FIELD 6530-00-709-8155 | Emerson-Sack-Warner Corp. | Jul 13, 1982 | SESE |
| [K801382](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K801382.md) | DISPOSABLE SURGICAL HEAD SUPPORT | Innovative Surgical Products, Inc. | Jun 26, 1980 | SESE |
| [K782092](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K782092.md) | ARMBOARD CVER, DISPOSABLE | Anago, Inc. | Jan 10, 1979 | SESE |
| [K780868](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K780868.md) | CHEST ROLLS | Devon Industries, Inc. | Aug 14, 1978 | SESE |
| [K780867](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K780867.md) | PAD HOLDER KIT | Devon Industries, Inc. | Aug 14, 1978 | SESE |
| [K780866](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K780866.md) | CHEST ROLLS HOLDER | Devon Industries, Inc. | Aug 14, 1978 | SESE |
| [K760308](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSE/K760308.md) | I.V. SUPPORT, TECNOL ARMBOARD | Tecnol New Jersey Wound Care, Inc. | Aug 11, 1976 | SESE |

## Top Applicants

- Devon Industries, Inc. — 3 clearances
- Tecnol New Jersey Wound Care, Inc. — 1 clearance
- Surgi-Quip Inc.U — 1 clearance
- Porex Medical — 1 clearance
- Orthopedic Systems, Inc. — 1 clearance

---

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

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