510(k) K210618
K210618 is an FDA 510(k) premarket notification submitted by Chongqing Jinshan Science & Technology Co., Ltd. for the device "Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series". The FDA issued a decision of Substantially Equivalent on Oct 20, 2021. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 20, 2021
- Date Received
- Mar 1, 2021
- 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
- 510(k)
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.