510(k) K181712
K181712 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "San Antonio Stopcock". The FDA issued a decision of Substantially Equivalent on Jul 26, 2018. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Cook Incorporated has 174 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 26, 2018
- Date Received
- Jun 28, 2018
- 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.