Crimper, Wire, Ent, Non-Sterile
The ENT wire crimper (non-sterile) is a prosthesis modification instrument used in ossicular replacement surgery to crimp wire components of middle ear prostheses to fit individual patient anatomy. 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 NNN does not require a 510(k) submission and is associated with product code JXT for reference.
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Basic Information
- Product Code
- NNN
- Device Class
- FDA class 1
- Regulation Number
- 874.3540
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
Definition
Prosthesis modification instrument for ossicular replacement surgery; see product code JXT.
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.