Holder, Speculum, Ent
A speculum holder for ENT use is an accessory instrument designed to hold and stabilize a speculum in position during examination or surgical procedures of the ear, nose, or throat, freeing the clinician's hands. It is classified as an FDA Class 1 device, subject only to general controls, reflecting its low-risk nature and the absence of a premarket notification requirement. Product code KAG is regulated under 21 CFR 878.1800 in the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KAG
- Device Class
- FDA class 1
- Regulation Number
- 878.1800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.