Saw, Nasal
A nasal saw is a surgical instrument used during rhinoplasty and nasal reconstructive procedures to cut through nasal bone in a controlled manner, facilitating osteotomies or bone reshaping. It is classified as an FDA Class 1 device, requiring only general controls and not subject to premarket notification. Product code KBC 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
- KBC
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K811887 | SKIN STAPLE EXTRACTOR | Jul 27, 1981 | Substantially Equivalent | Sierra Laboratories, Inc. |
| K810188 | AUTO SUTURE GAS POWERED DISP. LDS STAPL | Mar 20, 1981 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K810187 | AUTO SUTURE PSS SKIN STAPLING INSTRUMENT | Mar 20, 1981 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K772379 | JOSEPH SAW | Feb 02, 1978 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 61 registration numbers. Click on an entry to view related FDA registrations.