Product Code: KBP FDA class 1 21 CFR 874.4420

Hook, Tonsil Suturing

Ear, Nose, Throat

A tonsil suturing hook is a surgical instrument used during or after tonsillectomy to hold, manipulate, or position tonsillar tissue or sutures for the purpose of hemostasis or wound closure in the tonsillar fossa. 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 KBP 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
23
Registration Numbers
23
Unique Applicants
0
Years Active

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Basic Information

Product Code
KBP
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 23 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.