FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
K Number: K131848
·
Decision Mar 31, 2014
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
10
Review Days
283
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Basic Information
- Device Name
- VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
- K Number
- K131848
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Puricore, Inc.
- Date Received
- June 21, 2013
- Decision Date
- March 31, 2014
- 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 Puricore, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141863 | PURICORE WOUND HYDROGEL SPRAY DRESSING | May 14, 2015 | Substantially Equivalent |
| K123072 | VASHE WOUND THERAPY SOLUTION | Feb 14, 2013 | Substantially Equivalent |
| K123071 | VASHE SKIN AND WOUND HYDROGEL | Jan 24, 2013 | Substantially Equivalent |
| K100918 | VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 | Aug 9, 2010 | Substantially Equivalent |
| K093697 | VASHE WOUND THERAPY SOLUTION | Apr 13, 2010 | Substantially Equivalent |
| K093155 | VASHE WOUND CLEANSING SYSTEM | Mar 1, 2010 | Substantially Equivalent |
| K092232 | MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 | Aug 19, 2009 | Substantially Equivalent |
| K063159 | STERILOX LIQUID CHEMICAL STERILANT SYSTEM | Apr 2, 2007 | Substantially Equivalent |
| K061689 | AQUATINE EC ENDODONTIC CLEANSER | Aug 24, 2006 | Substantially Equivalent |