Saw, Surgical, Ent (Electric Or Pneumatic)
The ENT electric or pneumatic surgical saw is a powered instrument used to cut bone during ear, nose, and throat surgical procedures, including procedures such as rhinoplasty or craniofacial surgery. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The product code is EWQ, regulated under 21 CFR 874.4420 in the Ear, Nose, Throat specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EWQ
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.