510(k) K160117
K160117 is an FDA 510(k) premarket notification submitted by Medeon Biodesign, Inc. for the device "AbClose - Port Site Closure Device". The FDA issued a decision of Substantially Equivalent on September 9, 2016. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Medeon Biodesign, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2016
- Date Received
- January 19, 2016
- 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.