Product Code: JZF FDA class 1 21 CFR 874.4420

Tube, Ear Suction

Ear, Nose, Throat

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.

510(k)s
5
FEI Numbers
142
Registration Numbers
142
Unique Applicants
5
Years Active
15

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 5 510(k) clearances via K numbers.

K Number Device Name
K973587 EXMOOR TYMPANOCENTESIS KIT (TK/1)
K862903 MIDDLE EAR VIEWER AND FLUID COLLECTOR
K853589 SHAH SELF-CLEARING MASTOID SUCTION TUBE
K841357 MICRO FLUID APPLICATOR
K822010 RIGID SUCTION TIPS & RELATED ITEMS

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.