510(k) K192048
K192048 is an FDA 510(k) premarket notification submitted by Anrei Medical (Hangzhou) Co., Ltd. for the device "Single Use Endoscope Valves Set". The FDA issued a decision of Substantially Equivalent on May 14, 2020. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Anrei Medical (Hangzhou) Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2020
- Date Received
- July 31, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Channel Accessory
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To give the endoscope channel additional or improved functionality.