Trocar, Laryngeal
A laryngeal trocar is a sharp-pointed surgical instrument used in otolaryngology to puncture and create access into laryngeal structures during diagnostic or therapeutic procedures. Classified as FDA Class 1, the device is considered low risk and is subject only to general controls, with no premarket notification requirement. Product code KAB is regulated under 21 CFR 874.4420 within the Ear, Nose, Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KAB
- 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 |
|---|---|---|---|---|
| K022743 | REPROCESSED DISPOSABLE TROCARS | Oct 09, 2002 | Substantially Equivalent | Medical Device Services |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.