510(k) K183190
K183190 is an FDA 510(k) premarket notification submitted by Beeken Biomedical, LLC for the device "NuStat". The FDA issued a decision of Substantially Equivalent on September 25, 2019. The device falls under product code POD (Temporary, Internal Use Hemostatic), a Class II device regulated under 21 CFR 878.4454. Beeken Biomedical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2019
- Date Received
- November 19, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary, Internal Use Hemostatic
- Device Class
- Class II
- Regulation Number
- 878.4454
- Review Panel
- SU
- Submission Type
Intended to control severely bleeding wounds