510(k) K173650
K173650 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "AquaShield System CO2- Fujifilm". The FDA issued a decision of Substantially Equivalent on January 5, 2018. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2018
- Date Received
- November 28, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Air, Non-Manual, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type