510(k) K161020
K161020 is an FDA 510(k) premarket notification submitted by Revmedx, Inc. for the device "XSTAT-12, 3-Pack, XSTAT-12, 1-Pack". The FDA issued a decision of Substantially Equivalent on July 28, 2016. 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
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2016
- Date Received
- April 12, 2016
- Clearance Type
- Traditional
- 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.