510(k) K211149
K211149 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Urethral Warming Catheter Kit". The FDA issued a decision of Substantially Equivalent on Jan 5, 2022. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Varian Medical Systems, Inc. has 205 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 5, 2022
- Date Received
- Apr 19, 2021
- 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)