Product Code: DWI FDA class 1 21 CFR 878.4820

Saw, Electrically Powered

General, Plastic Surgery

The Electrically Powered Saw is a surgical power tool used to cut bone or hard tissue during surgical procedures in general or plastic surgery, providing efficient and controlled tissue division compared to manual methods. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DWI and it is regulated under 21 CFR 878.4820 within the General, Plastic Surgery medical specialty.

510(k)s
2
FEI Numbers
15
Registration Numbers
15
Unique Applicants
2
Years Active
11

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Basic Information

Product Code
DWI
Device Class
FDA class 1
Regulation Number
878.4820
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 2 510(k) clearances via K numbers.

K Number Device Name
K912237 STRYKER ECLIPSE WARMING STRETCHER
K801914 TEMP STERNUM SAW

FEI Numbers

This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.