Scissors, Ear
Scissors, Ear are fine surgical scissors designed for use in otological microsurgery to cut delicate tissues including the tympanic membrane, mucosal folds, fibrous tissue, and adhesions within the middle ear, with designs suited to the confined anatomy of the ear canal. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JZB, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
Basic Information
- Product Code
- JZB
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914226 | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | Nov 19, 1991 | Substantially Equivalent | E.I. DUPONT DE NEMOURS & CO., INC. |
| K870756 | VEIN GRAFT EAR SCISSORS | Mar 03, 1987 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K833603 | SCISSORS SHEA BELLUCC | Jan 03, 1984 | Substantially Equivalent | MICROTEK MEDICAL, INC. |
| K822196 | EAR SCISSORS | Aug 30, 1982 | Substantially Equivalent | KELLEHER CORP. |
FEI Numbers
This FDA classification entry is associated with 93 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.