510(k) K944415
K944415 is an FDA 510(k) premarket notification submitted by Origin Medsystems, Inc. for the device "ORIGIN TACKER SYSTEM". The FDA issued a decision of Substantially Equivalent on November 28, 1994. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Origin Medsystems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1994
- Date Received
- September 8, 1994
- 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.