Dissector, Tonsil
A tonsil dissector is a surgical instrument used during tonsillectomy to bluntly or sharply separate the tonsillar capsule from the surrounding pharyngeal tissue, facilitating complete removal of the tonsils. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KBM is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KBM
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K940903 | TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES | Apr 14, 1994 | Substantially Equivalent | Medical Insights, Inc. |
FEI Numbers
This FDA classification entry is associated with 62 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 62 registration numbers. Click on an entry to view related FDA registrations.