510(k) K110590
K110590 is an FDA 510(k) premarket notification submitted by Carl Zeiss Surgical GmbH for the device "INTRABEAM NEEDLE APPLICATOR". The FDA issued a decision of Substantially Equivalent on April 13, 2012. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Carl Zeiss Surgical GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2012
- Date Received
- March 2, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Therapeutic, X-Ray
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type