FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Phasix Mesh
K Number: K161424
·
Decision Sep 29, 2016
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
12
Applicant Total
3
Review Days
129
Basic Information
- Device Name
- Phasix Mesh
- K Number
- K161424
- 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
- C.R. BARD INC.
- Date Received
- May 23, 2016
- Decision Date
- September 29, 2016
- Product Code
- OOD
- 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 |
|---|---|---|---|
| OOD | Surgical Film | FDA class 2 | General, Plastic Surgery |
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Other Clearances by C.R. BARD INC.
| K Number | Device Name | ||
|---|---|---|---|
| K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners | May 31, 2017 | Substantially Equivalent |
| K160900 | CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners | May 31, 2016 | Substantially Equivalent |