K111020 is an FDA 510(k) clearance for the ATRICURE DISSECTOR. This device is classified as a Lamp, Surgical (Class II - Special Controls, product code FTD).
Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on June 9, 2011, 58 days after receiving the submission on April 12, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K111020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2011 |
| Decision Date | June 09, 2011 |
| Days to Decision | 58 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTD — Lamp, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |