510(k) DEN170015
DEN170015 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Hemospray Endoscopic Hemostat". The FDA issued a decision of De Novo Granted on May 7, 2018. The device falls under product code QAU (Hemostatic Device For Endoscopic Gastrointestinal Use), a Class II device regulated under 21 CFR 878.4456. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 7, 2018
- Date Received
- March 9, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostatic Device For Endoscopic Gastrointestinal Use
- Device Class
- Class II
- Regulation Number
- 878.4456
- Review Panel
- SU
- Submission Type
Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.