Block, Cutting, Ent, Sterile
Block, Cutting, ENT, Sterile is a sterile surgical accessory used in ear, nose, and throat (ENT) procedures as a cutting surface or guide to facilitate the precise shaping or cutting of prosthetic materials and implants during surgery. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JXS, regulated under 21 CFR 874.3540, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JXS
- Device Class
- FDA class 1
- Regulation Number
- 874.3540
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.