The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, A Division Of Tyco with the FDA for Sonicision Cordless Ultrasonic Dissection Device Model Scd391, Scd396, Sct12, Scg, Scb, Scsk, Sonicision Sterilization T.
| Device ID | K101797 |
| 510k Number | K101797 |
| Device Name: | SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO 5920 LONGBOW DRIVE Boulder, CO 80301 |
| Contact | David M Horton |
| Correspondent | David M Horton COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO 5920 LONGBOW DRIVE Boulder, CO 80301 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-28 |
| Decision Date | 2011-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521052666 | K101797 | 000 |
| 10884521037212 | K101797 | 000 |
| 20884521807874 | K101797 | 000 |
| 10884521133624 | K101797 | 000 |
| 10884521052659 | K101797 | 000 |
| 10884521036536 | K101797 | 000 |
| 20884524002955 | K101797 | 000 |
| 10884521807860 | K101797 | 000 |