510(k) K974137
K974137 is an FDA 510(k) premarket notification submitted by Uromed Corp. for the device "UROMED NEEDLE GRASPER". The FDA issued a decision of Substantially Equivalent on Jan 30, 1998. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Uromed Corp. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 30, 1998
- Date Received
- Nov 3, 1997
- 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
- 510(k)
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.