FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
Sinusway Dilation System
K Number: K181838
·
Decision Dec 20, 2018
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
64
Applicant Total
4
Review Days
163
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Basic Information
- Device Name
- Sinusway Dilation System
- K Number
- K181838
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3nt Medical , Ltd.
- Date Received
- July 10, 2018
- Decision Date
- December 20, 2018
- Product Code
- LRC
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | FDA class 1 | Ear, Nose, Throat |
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