510(k) K190829
K190829 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical Inc./Cook Endoscopy for the device "Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)". The FDA issued a decision of Substantially Equivalent on December 19, 2019. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Wilson-Cook Medical Inc./Cook Endoscopy has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2019
- Date Received
- April 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.