510(k) K032333
K032333 is an FDA 510(k) premarket notification submitted by Endocare, Inc. for the device "CRYOCARE CS SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 12, 2003. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Endocare, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2003
- Date Received
- July 29, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type