510(k) K163005
K163005 is an FDA 510(k) premarket notification submitted by Novus Scientific AB for the device "TIGR Matrix Surgical Mesh". The FDA issued a decision of Substantially Equivalent on July 27, 2017. The device falls under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia), a Class II device regulated under 21 CFR 878.3300. Novus Scientific AB has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2017
- Date Received
- October 28, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists during hernia repair.