510(k) K203350
K203350 is an FDA 510(k) premarket notification submitted by Nissha Medical Technologies Sas for the device "ENDOtube". The FDA issued a decision of Substantially Equivalent on Sep 29, 2021. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Nissha Medical Technologies Sas has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 2021
- Date Received
- Nov 13, 2020
- 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.