510(k) K182259
K182259 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal". The FDA issued a decision of Substantially Equivalent on February 7, 2019. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Acell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2019
- Date Received
- August 21, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type