Product Code: JYT FDA class 1 21 CFR 874.4420

Pick, Microsurgical Ear

Ear, Nose, Throat

Pick, Microsurgical Ear is a delicate, pointed surgical instrument used in microsurgical procedures of the middle ear to manipulate fine structures such as the ossicles, perilymph, or fibrous annulus, and to test the mobility of ossicular prostheses after placement. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JYT, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

510(k)s
2
FEI Numbers
75
Registration Numbers
75
Unique Applicants
2
Years Active
2

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Basic Information

Product Code
JYT
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
K841355 RIGHT ANGLED PICK
K822176 MICROSURGICAL EAR PICKS

FEI Numbers

This FDA classification entry is associated with 75 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 75 registration numbers. Click on an entry to view related FDA registrations.