510(k) DEN130016
DEN130016 is an FDA 510(k) premarket notification submitted by Revmedx, Inc. for the device "XSTAT". The FDA issued a decision of De Novo Granted on April 3, 2014. The device falls under product code PGZ (Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use), a Class II device regulated under 21 CFR 878.4452. Revmedx, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 3, 2014
- Date Received
- January 30, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
- Device Class
- Class II
- Regulation Number
- 878.4452
- Review Panel
- SU
- Submission Type
To control bleeding in junctional, non-compressible wounds until surgical care is acquired.