FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ETHMOID SINUS SPACER
K Number: K062458
·
Decision Sep 15, 2006
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
18
Applicant Total
45
Review Days
23
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Basic Information
- Device Name
- ETHMOID SINUS SPACER
- K Number
- K062458
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acclarent, Inc.
- Date Received
- August 23, 2006
- Decision Date
- September 15, 2006
- Product Code
- KAM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KAM | Cannula, Sinus | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KAM), ordered by most recent decision date.
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
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MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
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RELIEVA STRATUS MICROFLOW SPACER
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RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
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RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
FDA 510(k)
FDA Class 1
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