FSE · Table, Operating-Room, Manual
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | FSE |
|---|---|
| Device Name | Table, Operating-Room, Manual |
| Regulation | 21 CFR 878.4950 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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 | THE POREX RETRACTOR TABLE | Porex Medical | Mar 13, 1986 | SESE |
| K843801 | MASON EQUIPMENT ORGANIZER & ASPEN | Aspen Laboratories, Inc. | Oct 25, 1984 | SESE |
| K840027 | OPERATING ROOM STAND | Healthmate, Inc. | Feb 4, 1984 | SESE |
| K831042 | CHEMONUCLEOLYSIS TABLE EXTENSION | Orthopedic Systems, Inc. | May 16, 1983 | SESE |
| K830339 | IMSI/METRIPOND HAND OPERATING TABLE | Intl. Management Services, Inc. | Apr 12, 1983 | SESE |
| K822427 | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | Surgi-Quip Inc.U | Sep 14, 1982 | SESE |
| K821924 | TABLE, OPERATING, FIELD 6530-00-709-8155 | Emerson-Sack-Warner Corp. | Jul 13, 1982 | SESE |
| K801382 | DISPOSABLE SURGICAL HEAD SUPPORT | Innovative Surgical Products, Inc. | Jun 26, 1980 | SESE |
| K782092 | ARMBOARD CVER, DISPOSABLE | Anago, Inc. | Jan 10, 1979 | SESE |
| K780868 | CHEST ROLLS | Devon Industries, Inc. | Aug 14, 1978 | SESE |
| K780867 | PAD HOLDER KIT | Devon Industries, Inc. | Aug 14, 1978 | SESE |
| K780866 | CHEST ROLLS HOLDER | Devon Industries, Inc. | Aug 14, 1978 | SESE |
| K760308 | 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
