FWW · Table, Operating-Room, Pneumatic
General, Plastic Surgery · 21 CFR 878.4960 · Class 1
Overview
| Product Code | FWW |
|---|---|
| Device Name | Table, Operating-Room, Pneumatic |
| Regulation | 21 CFR 878.4960 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.
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 § 878.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953961 | OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM | Osteonics Corp. | Nov 29, 1995 | SESE |
| K935356 | CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES | Amsco American Sterilizer Co. | Mar 23, 1994 | SESE |
| K931876 | FISK ARM SUPPORT | Vvortex International Corp. | Sep 9, 1993 | SESE |
| K924713 | UNIVERSAL SURGICAL INSTRUMENT HOLDER | T. Korossurgical Instruments Corp. | May 17, 1993 | SESE |
| K863161 | TABLE, OPERATING ROOM, HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | Sep 5, 1986 | SESE |
| K853479 | SKYTRON ELITE 300 SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | Sep 5, 1985 | SESE |
Top Applicants
- Vvortex International Corp. — 1 clearance
- T. Korossurgical Instruments Corp. — 1 clearance
- Skytron, Div. the Kmw Group, Inc. — 1 clearance
- Osteonics Corp. — 1 clearance
- Kamiya Tsusan Kaisha, Ltd. — 1 clearance
