FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Microcyn Plus Wound Care Solution
K Number: K161034
·
Decision Aug 19, 2016
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
9
Review Days
128
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Basic Information
- Device Name
- Microcyn Plus Wound Care Solution
- K Number
- K161034
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oculus Innovative Sciences
- Date Received
- April 13, 2016
- Decision Date
- August 19, 2016
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Oculus Innovative Sciences
| K Number | Device Name | ||
|---|---|---|---|
| K162217 | LOYON | Mar 23, 2017 | Substantially Equivalent |
| K153648 | Microcyn Plus Skin and Wound Hydrogel | Apr 19, 2016 | Substantially Equivalent |
| K152945 | Alevicyn SG Antipruritic Gel | Dec 15, 2015 | Substantially Equivalent |
| K152055 | Ceramax Skin Barrier Cream | Nov 23, 2015 | Substantially Equivalent |
| K143590 | Alevicyn SG Antipruritic Gel | Jun 4, 2015 | Substantially Equivalent |
| K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | Aug 18, 2014 | Substantially Equivalent |
| K141012 | HYDROCLEANSE WOUND CARE SOLUTION | Aug 8, 2014 | Substantially Equivalent |
| K131672 | MICROCYN SCAR MANAGEMENT HYDROGEL | Nov 15, 2013 | Substantially Equivalent |