510(k) K221897
K221897 is an FDA 510(k) premarket notification submitted by Bibawo Medical A/S for the device "Hydrozid Precise". The FDA issued a decision of Substantially Equivalent on May 30, 2023. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2023
- Date Received
- Jun 30, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type
- 510(k)