LWG · Surgical Table Cushion
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | LWG |
|---|---|
| Device Name | Surgical Table Cushion |
| 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 |
|---|---|---|---|---|
| K883295 | CHOP SPINE FRAME | Avec Scientific Design Corp. | Aug 23, 1988 | SESE |
| K882520 | SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS | Karlin Technology, Inc. | Jul 18, 1988 | SESE |
| K874494 | KAMBIN LAMINECTOMY FRAME | Avec Scientific Design Corp. | Nov 23, 1987 | SESE |
| K873690 | CEDAR(TM) PELVIC CUSHION | Cedar Surgical, Inc. | Oct 26, 1987 | SESE |
Top Applicants
- Avec Scientific Design Corp. — 2 clearances
- Cedar Surgical, Inc. — 1 clearance
- Karlin Technology, Inc. — 1 clearance
