510(k) K170945
K170945 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Biodesign Staple Line Reinforcement". The FDA issued a decision of Substantially Equivalent on April 28, 2017. The device falls under product code OXE (Mesh, Surgical, Collagen, Staple Line Reinforcement), a Class II device regulated under 21 CFR 878.3300. Cook Biotech Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2017
- Date Received
- March 30, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Collagen, Staple Line Reinforcement
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.