510(k) K111020
K111020 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "ATRICURE DISSECTOR". The FDA issued a decision of Substantially Equivalent on June 9, 2011. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. AtriCure, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2011
- Date Received
- April 12, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type