FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADVACOAT SINUS GEL AND STENT
K Number: K070496
·
Decision Mar 15, 2007
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
2
Review Days
23
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Basic Information
- Device Name
- ADVACOAT SINUS GEL AND STENT
- K Number
- K070496
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 874.4780
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carbylan Biosurgery
- Date Received
- February 20, 2007
- Decision Date
- March 15, 2007
- Product Code
- LYA
- 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 |
|---|---|---|---|
| LYA | Splint, Intranasal Septal | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Carbylan Biosurgery
| K Number | Device Name | ||
|---|---|---|---|
| K063308 | ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 | Dec 4, 2006 | Substantially Equivalent |