Product Code: KBR FDA class 1 21 CFR 874.4420

Needle, Tonsil Suturing

Ear, Nose, Throat

A tonsil suturing needle is a curved surgical needle specifically designed for placing sutures in the tonsillar fossa following tonsillectomy to achieve hemostasis or close the wound bed. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket notification. Product code KBR is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.

510(k)s
0
FEI Numbers
37
Registration Numbers
37
Unique Applicants
0
Years Active

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Basic Information

Product Code
KBR
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

FEI Numbers

This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.