510(k) K180053
K180053 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Sof-Flex Ureteral Stent Set". The FDA issued a decision of Substantially Equivalent on Sep 13, 2018. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Cook Incorporated has 174 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 13, 2018
- Date Received
- Jan 8, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.4620
- Review Panel
- GU
- Submission Type
- 510(k)