Surgical Table Cushion
The Surgical Table Cushion (product code LWG) is a general-purpose accessory placed on a surgical table to provide patient positioning, comfort, and pressure relief during surgical procedures. Regulated under 21 CFR 878.4950 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery medical specialty. The device is GMP-exempt and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- LWG
- Device Class
- FDA class 1
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883295 | CHOP SPINE FRAME | Aug 23, 1988 | Substantially Equivalent | Avec Scientific Design Corp. |
| K882520 | SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS | Jul 18, 1988 | Substantially Equivalent | Karlin Technology, Inc. |
| K874494 | KAMBIN LAMINECTOMY FRAME | Nov 23, 1987 | Substantially Equivalent | Avec Scientific Design Corp. |
| K873690 | CEDAR(TM) PELVIC CUSHION | Oct 26, 1987 | Substantially Equivalent | Cedar Surgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.