Hook, Microsurgical Ear
Hook, Microsurgical Ear is a fine surgical instrument used in microsurgical procedures of the middle ear to manipulate, mobilize, or displace delicate ossicular structures, membranes, and tissues without causing trauma. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JYL, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JYL
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K834188 | JAKOBI SURG. INSTRUMENTS #7 10/43 | Mar 06, 1984 | Substantially Equivalent | Imm Enterprises , Ltd. |
| K822195 | MIRCOSURGICAL INSTRUMENTS | Aug 25, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822166 | MICROSURGICAL EAR HOOK | Aug 20, 1982 | Substantially Equivalent | Kelleher Corp. |
| K780287 | DAY HEAR HOOK | Feb 27, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772390 | DAY EAR HOOK | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 88 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 88 registration numbers. Click on an entry to view related FDA registrations.