FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Biodesign Staple Line Reinforcement
K Number: K170945
·
Decision Apr 28, 2017
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
3
Applicant Total
16
Review Days
29
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Basic Information
- Device Name
- Biodesign Staple Line Reinforcement
- K Number
- K170945
- 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
- Cook Biotech Incorporated
- Date Received
- March 30, 2017
- Decision Date
- April 28, 2017
- Product Code
- OXE
- 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 |
|---|---|---|---|
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXE), ordered by most recent decision date.
Kerecis SecureMesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERITAS COLLAGEN MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGISIS STAPLE LINE REINFORCEMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Cook Biotech Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | May 24, 2024 | Substantially Equivalent |
| K201000 | Biodesign Staple Line Reinforcement | Jul 13, 2020 | Substantially Equivalent |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft | Dec 27, 2019 | Substantially Equivalent |
| K171817 | Biodesign Diaphragmatic Hernia Graft | Mar 13, 2018 | Substantially Equivalent |
| K162934 | Biodesign Parastomal Hernia Repair Graft | Jul 10, 2017 | Substantially Equivalent |
| K170016 | Biodesign Fistula Plug | Jun 21, 2017 | Substantially Equivalent |
| K161762 | DynaMatrix/Dynamatrix Plus | Jan 13, 2017 | Substantially Equivalent |
| K162741 | AxoGuard Nerve Connector | Oct 31, 2016 | Substantially Equivalent |
| K160136 | Flowable Wound Matrix | Sep 28, 2016 | Substantially Equivalent |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | May 26, 2016 | Substantially Equivalent |