510(k) K153364
K153364 is an FDA 510(k) premarket notification submitted by Kerecis Limited for the device "Kerecis SecureMesh". The FDA issued a decision of Substantially Equivalent on August 19, 2016. The device falls under product code OXE (Mesh, Surgical, Collagen, Staple Line Reinforcement), a Class II device regulated under 21 CFR 878.3300. Kerecis Limited has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2016
- Date Received
- November 20, 2015
- Clearance Type
- Traditional
- 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.