510(k) K152278
K152278 is an FDA 510(k) premarket notification submitted by Promepla Sam for the device "ENDOFLOW II - Irrigation, Warming and Suction System". The FDA issued a decision of Substantially Equivalent on February 9, 2016. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Promepla Sam has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2016
- Date Received
- August 12, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Irrigation/Suction System
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.