510(k) K092726
K092726 is an FDA 510(k) premarket notification submitted by Surgical Structures , Ltd. for the device "MESH GPS - LARGE, SMALL, SM, SM SMALL". The FDA issued a decision of Substantially Equivalent on March 15, 2010. The device falls under product code OQL (Mesh, Surgical, Deployment Balloon), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2010
- Date Received
- September 3, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Deployment Balloon
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.