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SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T

K101797 Traditional
Decision Date
2011-02-24
Sponsor / Applicant
Covidien, Formerly Valleylab, A Division of Tyco

Technical Specification

510(k) Submission ID K101797
Product Code LFL
Medical Specialty / Panel Unknown
Decision Date 2011-02-24
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T received FDA 510(k) clearance under submission number K101797, sponsored by Covidien, Formerly Valleylab, A Division of Tyco. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2011-02-24.

Classification & Regulation

This clearance is catalogued under FDA product code LFL , within the Unknown review panel as a device.