510(k) K171602
K171602 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Williams Cystoscopic Injection Needle". The FDA issued a decision of Substantially Equivalent on Jul 28, 2017. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Cook Incorporated has 174 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 2017
- Date Received
- Jun 1, 2017
- 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
- 510(k)
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.