510(k) K230599
K230599 is an FDA 510(k) premarket notification submitted by Recensmedical, Inc. for the device "TargetCool". The FDA issued a decision of Substantially Equivalent on June 22, 2023. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Recensmedical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2023
- Date Received
- March 3, 2023
- 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