510(k) K261684
K261684 is an FDA 510(k) premarket notification submitted by Cryosurgery, Inc. for the device "FreezeSpray TA". The FDA issued a decision of Substantially Equivalent on September 5, 2026. The device falls under product code MLY (Vapocoolant Device), a Class U device. Cryosurgery, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2026
- Date Received
- May 21, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vapocoolant Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type