FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRAFT PATCH
K Number: K970561
·
Decision Aug 1, 1997
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
12
Review Days
169
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
- GRAFT PATCH
- K Number
- K970561
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Organogenesis, Inc.
- Date Received
- February 13, 1997
- Decision Date
- August 1, 1997
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTL), ordered by most recent decision date.
ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Parietene Flat Sheet Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Onflex Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bard® Mesh; Bard® Mesh Pre-Shaped
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Parietene Macroporous Mesh (PPM5050 )
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Organogenesis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix) | May 2, 2023 | Substantially Equivalent |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | Jul 1, 2022 | Substantially Equivalent |
| K071555 | FORTAGEN ORAL MEMBRANE | Aug 30, 2007 | Substantially Equivalent |
| K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | Nov 8, 2005 | Substantially Equivalent |
| K042809 | CUFFPATCH | Nov 2, 2004 | Substantially Equivalent |
| K021107 | FORTAFLEX SURGICAL SLING | May 15, 2002 | Substantially Equivalent |
| K021105 | FORTAFLEX SURGICAL MESH | May 10, 2002 | Substantially Equivalent |
| K020049 | FORTAFLEX SURGICAL MESH | Mar 18, 2002 | Substantially Equivalent |
| K011025 | FORTAFLEX SURGICAL MESH | Aug 24, 2001 | Substantially Equivalent |
| K011026 | FORTADERM WOUND DRESSING | Jun 13, 2001 | Substantially Equivalent |