510(k) K200388
K200388 is an FDA 510(k) premarket notification submitted by Ga Health Company Limited for the device "Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector". The FDA issued a decision of Substantially Equivalent on April 14, 2020. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Ga Health Company Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2020
- Date Received
- February 18, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.