Product Code: LWG FDA class 1 21 CFR 878.4950

Surgical Table Cushion

General, Plastic Surgery

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.

510(k)s
4
FEI Numbers
58
Registration Numbers
58
Unique Applicants
3
Years Active
1

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number Device Name
K883295 CHOP SPINE FRAME
K882520 SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS
K874494 KAMBIN LAMINECTOMY FRAME
K873690 CEDAR(TM) PELVIC CUSHION

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.