Product Code: JYH FDA class 1 21 CFR 874.4420

Excavator, Ear

Ear, Nose, Throat

Excavator, Ear is a surgical hand instrument used to excavate or scrape soft tissue or bony material in the ear canal or middle ear space, employed in procedures such as mastoidectomy or cholesteatoma removal. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JYH, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

510(k)s
0
FEI Numbers
55
Registration Numbers
55
Unique Applicants
0
Years Active

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Basic Information

Product Code
JYH
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

FEI Numbers

This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.