510(k) K133747
K133747 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 January 8, 2014. 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
- January 8, 2014
- Date Received
- December 9, 2013
- 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