510(k) K162142
K162142 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Accessory Irrigation Adapter". The FDA issued a decision of Substantially Equivalent on Apr 27, 2017. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Wilson-Cook Medical, Inc. has 125 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 2017
- Date Received
- Aug 1, 2016
- 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
- 510(k)
To give the endoscope channel additional or improved functionality.