Product Code: NNU FDA class 1 21 CFR 874.3540

Scissors, Wire Cutting, Ent, Non-Sterile

Ear, Nose, Throat

The ENT wire cutting scissors (non-sterile) is a prosthesis modification instrument used in ossicular replacement surgery to cut wire components of middle ear prostheses to the appropriate length. It is classified as FDA Class 1 under regulation 874.3540 in the Ear, Nose, and Throat specialty, and it is GMP exempt. Product code NNU does not require a 510(k) submission and is associated with product code JYA.

510(k)s
0
FEI Numbers
31
Registration Numbers
31
Unique Applicants
0
Years Active

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Basic Information

Product Code
NNU
Device Class
FDA class 1
Regulation Number
874.3540
Medical Specialty
Ear, Nose, Throat
Review Panel
EN
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

Prosthesis modification instrument for ossicular replacement surgery; see product code JYA.

FEI Numbers

This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.