Knife, Ear
Knife, Ear is a fine surgical cutting instrument used in otological procedures to make precise incisions in the ear canal skin, tympanic membrane, or middle ear structures during operations such as tympanoplasty, myringoplasty, or stapedectomy. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYO, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JYO
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K910212 | COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST | Jul 11, 1991 | Substantially Equivalent | Acoustic Imaging Technologies Corp. |
| K841006 | EAR KNIFE-VARIOUS | May 30, 1984 | Substantially Equivalent | Premier Dental Products Co. |
| K840764 | EAR KNIVES | May 21, 1984 | Substantially Equivalent | Sharpoint, Inc. |
| K833602 | ROLLER KNIFE-TRANSVERSE -SAGITTAL | Jan 03, 1984 | Substantially Equivalent | Microtek Medical, Inc. |
| K823911 | KNIFE BLADE TIP | Jan 21, 1983 | Substantially Equivalent | Treace Medical, Inc. |
| K772384 | MYRINGOTOMY KNIFE | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772372 | ROLLER KNIFE | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 81 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 81 registration numbers. Click on an entry to view related FDA registrations.