510(k) K140441
K140441 is an FDA 510(k) premarket notification submitted by Promepla Sam for the device "BI-FLEX URETERAL ACCESS SHEATH". The FDA issued a decision of Substantially Equivalent on June 17, 2014. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Promepla Sam has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2014
- Date Received
- February 21, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Catheter, G-U
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type