510(k) K191231
K191231 is an FDA 510(k) premarket notification submitted by Smartdata Suzhou Co., Ltd. for the device "Andorate Auxiliary Water Connector, Andorate Valves Set". The FDA issued a decision of Substantially Equivalent on Jun 7, 2019. The device falls under product code ODC (Endoscope Channel Accessory), 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
- Jun 7, 2019
- Date Received
- May 8, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Endoscope Channel Accessory
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To give the endoscope channel additional or improved functionality.