510(k) K070894
K070894 is an FDA 510(k) premarket notification submitted by Tepha, Inc. for the device "TEPHAFLEX SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on April 13, 2007. The device falls under product code OOD (Surgical Film), a Class II device regulated under 21 CFR 878.3300. Tepha, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2007
- Date Received
- March 30, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Film
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.