Product Code: JZD FDA class 1 21 CFR 874.4420

Snare, Ear

Ear, Nose, Throat

Snare, Ear is a surgical instrument consisting of a wire loop used to encircle and remove polyps, granulation tissue, or other soft tissue masses from within the ear canal or middle ear, typically with an electrosurgical or mechanical cutting action. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JZD, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

510(k)s
2
FEI Numbers
35
Registration Numbers
35
Unique Applicants
2
Years Active
1

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Basic Information

Product Code
JZD
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
K834168 FIBRINOGEN UPTAKE SYS -VARIOUS MODELS
K822199 EAR SNARES

FEI Numbers

This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.