Cleared Traditional

HARMONIC SCALPEL BLADES AND SHEARS

K060245 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery
Apr 2006
Decision
66d
Days
Risk

About This 510(k) Submission

K060245 is an FDA 510(k) clearance for the HARMONIC SCALPEL BLADES AND SHEARS, a Instrument, Ultrasonic Surgical, submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 7, 2006, 66 days after receiving the submission on January 31, 2006. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K060245 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2006
Decision Date April 07, 2006
Days to Decision 66 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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