FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SMARTSPONGE PLUS SYSTEM
K Number: K073180
·
Decision Nov 19, 2007
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
14
Applicant Total
2
Review Days
6
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Basic Information
- Device Name
- SMARTSPONGE PLUS SYSTEM
- K Number
- K073180
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clearcount Medical Solutions, Inc.
- Date Received
- November 13, 2007
- Decision Date
- November 19, 2007
- Product Code
- LWH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LWH | Counter, Sponge, Surgical | FDA class 1 | General Hospital |
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Other Clearances by Clearcount Medical Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071355 | SMARTSPONGE SYSTEM | May 24, 2007 | Substantially Equivalent |