K101797 is an FDA 510(k) clearance for the SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Covidien, Formerly Valleylab, A Division of Tyco (Boulder, US). The FDA issued a Cleared decision on February 24, 2011, 241 days after receiving the submission on June 28, 2010.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K101797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2010 |
| Decision Date | February 24, 2011 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |