510(k) K161482
K161482 is an FDA 510(k) premarket notification submitted by Endochoice, Inc. for the device "EndoChoice Water Bottle Cap Irrigation System". The FDA issued a decision of Substantially Equivalent on June 27, 2016. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Endochoice, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2016
- Date Received
- May 31, 2016
- 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