Inserter, Myringotomy Tube
Inserter, Myringotomy Tube is a surgical instrument used to place a tympanostomy (myringotomy) tube through the eardrum during a myringotomy procedure, performed to ventilate the middle ear and treat recurrent otitis media or persistent middle ear effusion. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JYM, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JYM
- 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 |
|---|---|---|---|---|
| K924901 | DEANS DISPOSABLE T-TUBE INSERTER | Jan 28, 1993 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K870978 | T-TUBE INSERTER | Mar 19, 1987 | Substantially Equivalent | Sur-Med Instruments, Inc. |
| K822349 | ARMSTRONG V TUBE SUCTION INSERTER | Sep 13, 1982 | Substantially Equivalent | Treace Medical, Inc. |
| K822348 | TYTAN TUBE INSERTER | Sep 07, 1982 | Substantially Equivalent | Treace Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.