Cleared Traditional

K100597 - HARMONIC FOCUS SHEARS

K100597 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
36d
Days
-
Risk

K100597 is an FDA 510(k) clearance for the HARMONIC FOCUS SHEARS. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on April 7, 2010 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K100597

510(k) Number K100597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2010
Decision Date April 07, 2010
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 157
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K100597.
CUSA NXT EXTENDED LENGTH TIP
K102258 · Integra Radionics, Inc. · Jun 2011
SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T
K101797 · Covidien, Formerly Valleylab, A Division of Tyco · Feb 2011
TX1 TISSUE REMOVAL SYSTEM
K101561 · American Optisurgical, Inc. · Aug 2010
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K090864 · Integra Radionics, Inc. · May 2009
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
K081459 · Integra Radionics, Inc. · Aug 2008
SONOCA 180/195 WOUND CARE SYSTEM
K072904 · Soering GmbH · May 2008
K100597 · HARMONIC FOCUS SHEARS
Download PDF FDA Summary Ethicon Endo-Surgery,…