Tube, Ear Suction
Tube, Ear Suction is a narrow surgical suction tube designed for use in the ear canal or middle ear to aspirate blood, secretions, irrigation fluid, or debris during otological procedures, maintaining a clear surgical field under the operating microscope. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JZF, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JZF
- 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 |
|---|---|---|---|---|
| K973587 | EXMOOR TYMPANOCENTESIS KIT (TK/1) | Jan 23, 1998 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K862903 | MIDDLE EAR VIEWER AND FLUID COLLECTOR | Nov 24, 1986 | Substantially Equivalent | Steven K. Juhn |
| K853589 | SHAH SELF-CLEARING MASTOID SUCTION TUBE | Dec 23, 1985 | Substantially Equivalent | Downs Surgical , Ltd. |
| K841357 | MICRO FLUID APPLICATOR | Aug 24, 1984 | Substantially Equivalent | Treace Medical, Inc. |
| K822010 | RIGID SUCTION TIPS & RELATED ITEMS | Aug 12, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 142 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 142 registration numbers. Click on an entry to view related FDA registrations.