FWY · Table, Operating-Room, Non-Electrical
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | FWY |
|---|---|
| Device Name | Table, Operating-Room, Non-Electrical |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883457 | ASST-3000 SPINAL SURGERY TABLE | Orthopedic Systems, Inc. | Aug 26, 1988 | SESE |
| K873478 | SKYTRON MODEL 130 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | Sep 24, 1987 | SESE |
| K833509 | CHEMONUCLEOLYSIS TABLE | Stryker Corp. | Nov 28, 1983 | SESE |
| K800118 | CHICK SURGICAL TABLE | Warner-Lambert Co. | Feb 5, 1980 | SESE |
Top Applicants
- Orthopedic Systems, Inc. — 1 clearance
- Skytron, Div. the Kmw Group, Inc. — 1 clearance
- Stryker Corp. — 1 clearance
- Warner-Lambert Co. — 1 clearance
