Product Code: EWQ FDA class 1 21 CFR 874.4420

Saw, Surgical, Ent (Electric Or Pneumatic)

Ear, Nose, Throat

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.

510(k)s
2
FEI Numbers
7
Registration Numbers
7
Unique Applicants
2
Years Active
5

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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

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
K844765 ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
K800669 FELDMAN MINI-SAW, #300000

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.