510(k) K073671
K073671 is an FDA 510(k) premarket notification submitted by Ndo Surgical, Inc. for the device "PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 26, 2008. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Ndo Surgical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2008
- Date Received
- December 27, 2007
- 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.