510(k) K102931
K102931 is an FDA 510(k) premarket notification submitted by Usgi Medical for the device "G-CINCH SUTURE GRASPER". The FDA issued a decision of Substantially Equivalent on December 30, 2010. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Usgi Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2010
- Date Received
- October 4, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Tissue Approximation Device
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.