510(k) K173105
K173105 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter". The FDA issued a decision of Substantially Equivalent on Mar 22, 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
- Mar 22, 2018
- Date Received
- Sep 29, 2017
- 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.