510(k) K161337
K161337 is an FDA 510(k) premarket notification submitted by Nuance Medical, LLC for the device "CryoDose H or Similar". The FDA issued a decision of Substantially Equivalent on July 12, 2016. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Nuance Medical, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2016
- Date Received
- May 13, 2016
- 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