510(k) K191366
K191366 is an FDA 510(k) premarket notification submitted by Smartdata Suzhou Co., Ltd. for the device "Vacutore Air/Water Bottle Tubing". The FDA issued a decision of Substantially Equivalent on Sep 6, 2019. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Smartdata Suzhou Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 6, 2019
- Date Received
- May 22, 2019
- 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
- 510(k)
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.