FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CISNAP CLOSED INCISION SYSTEM
K Number: K133137
·
Decision Feb 25, 2014
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
16
Applicant Total
9
Review Days
137
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Basic Information
- Device Name
- CISNAP CLOSED INCISION SYSTEM
- K Number
- K133137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4683
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spiracur, Inc.
- Date Received
- October 11, 2013
- Decision Date
- February 25, 2014
- Product Code
- OKO
- 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 |
|---|---|---|---|
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OKO), ordered by most recent decision date.
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Other Clearances by Spiracur, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151710 | SNaP Wound Care System | Nov 19, 2015 | Substantially Equivalent |
| K142272 | SNaP Wound Care System | Nov 25, 2014 | Substantially Equivalent |
| K132080 | SNAP WOUND CARE SYSTEM | Mar 12, 2014 | Substantially Equivalent |
| K113032 | SNAP WOUND CARE SYSTEM | Dec 1, 2011 | Substantially Equivalent |
| K112341 | SNAP WOUND CARE SYSTEM | Aug 29, 2011 | Substantially Equivalent |
| K111393 | SNAP (R) WOUND CARE SYSTEM | Jul 28, 2011 | Substantially Equivalent |
| K111006 | CI-SNAP WOUND CARE SYSTEM | Jul 21, 2011 | Substantially Equivalent |
| DEN080011 | SNAP WOUND CARE DEVICE | Aug 7, 2009 | Unknown |