510(k) K171917
K171917 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Frova Intubating Introducer". The FDA issued a decision of Substantially Equivalent on Apr 23, 2018. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Cook Incorporated has 174 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 2018
- Date Received
- Jun 27, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type
- 510(k)