510(k) K213198
K213198 is an FDA 510(k) premarket notification submitted by Advamedica, Inc. for the device "Ax-Surgi Surgical Hemostat". The FDA issued a decision of Substantially Equivalent on January 5, 2023. The device falls under product code POD (Temporary, Internal Use Hemostatic), a Class II device regulated under 21 CFR 878.4454. Advamedica, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2023
- Date Received
- September 29, 2021
- 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