FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Gentrix Surgical Matrix
K Number: K162554
·
Decision Oct 21, 2016
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
20
Review Days
38
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Gentrix Surgical Matrix
- K Number
- K162554
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acell, Inc.
- Date Received
- September 13, 2016
- Decision Date
- October 21, 2016
- Product Code
- FTM
- 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTM), ordered by most recent decision date.
Endoform Reconstructive Template - PLGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS (Long-Term Resorbable)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CanGaroo RM Antibacterial Envelope
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Peri-Guard and Supple Peri-Guard
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS (Long Term Resorbable)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Acell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241706 | MicroMatrix® UBM Particulate | Jul 11, 2024 | Substantially Equivalent |
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | Jul 11, 2024 | Substantially Equivalent |
| K230980 | MicroMatrix® Flex | Sep 22, 2023 | Substantially Equivalent |
| K191734 | MatriStem UBM Pericardial Patch | Nov 22, 2019 | Substantially Equivalent |
| K192725 | Cytal Wound Matrix 3-Layer | Oct 25, 2019 | Substantially Equivalent |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | Feb 7, 2019 | Substantially Equivalent |
| 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 |
| K153754 | MicroMatrix | Mar 14, 2016 | Substantially Equivalent |