510(k) K253114
K253114 is an FDA 510(k) premarket notification submitted by Recensmedical, Inc. for the device "TargetCool (RM-DT02W)". The FDA issued a decision of Substantially Equivalent on October 16, 2025. 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
- October 16, 2025
- Date Received
- September 24, 2025
- Clearance Type
- Special
- 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