FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MicroMatrix
K Number: K153754
·
Decision Mar 14, 2016
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
20
Review Days
76
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Basic Information
- Device Name
- MicroMatrix
- K Number
- K153754
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acell, Inc.
- Date Received
- December 29, 2015
- Decision Date
- March 14, 2016
- Product Code
- KGN
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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| K180776 | Cytal Wound Particulate | May 11, 2018 | Substantially Equivalent |
| K172399 | MicroMatrix | Oct 6, 2017 | Substantially Equivalent |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | Jun 8, 2017 | Substantially Equivalent |
| K162554 | Gentrix Surgical Matrix | Oct 21, 2016 | Substantially Equivalent |