FWX · Table, Operating-Room, Mechanical
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | FWX |
|---|---|
| Device Name | Table, Operating-Room, Mechanical |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884019 | ALM OPERATING TABLES | Alm Surgical Equipment, Inc. | Oct 13, 1988 | SESE |
| K841116 | MOBILE OPHTHALMIC OPERATING TABLE | Surgi-Quip Inc.U | May 9, 1984 | SESE |
| K821923 | TABLE, OPERATING, FIELD 6530-00-709-8175 | Emerson-Sack-Warner Corp. | Jul 13, 1982 | SESE |
Top Applicants
- Alm Surgical Equipment, Inc. — 1 clearance
- Emerson-Sack-Warner Corp. — 1 clearance
- Surgi-Quip Inc.U — 1 clearance
