510(k) K181141
K181141 is an FDA 510(k) premarket notification submitted by Apollo Endosurgery for the device "OverStitch Endoscopic Suturing System and Accessories". The FDA issued a decision of Substantially Equivalent on June 27, 2018. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Apollo Endosurgery has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2018
- Date Received
- May 1, 2018
- Clearance Type
- Special
- 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.