LFL

FDA Product Code LFL: Instrument, Ultrasonic Surgical

Ultrasonic energy has transformed minimally invasive surgery by providing a single tool for simultaneous cutting and coagulation. FDA product code LFL covers ultrasonic surgical instruments.

These devices use high-frequency mechanical vibrations to cut tissue and coagulate blood vessels simultaneously, with minimal thermal spread and smoke generation compared to electrosurgical devices. They are widely used in laparoscopic, robotic, and open surgical procedures.

LFL devices are reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Ethicon Endo-Surgery, Inc., Ethicon Endo-Surgery, LLC and Integra LifeSciences Corporation.

160
Total
160
Cleared
123d
Avg days
1980
Since
160 devices
49–72 of 160
Cleared May 29, 2015
Prime Adaptive Ultrasonic Scalpel System
K150271
Endoprime, Inc.
General & Plastic Surgery · 114d
Cleared Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K141668
Integra LifeSciences Corporation
General & Plastic Surgery · 136d
Cleared Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K141674
Integra LifeSciences Corporation
General & Plastic Surgery · 136d
Cleared Aug 07, 2014
SONICISION CORDLESS ULTRASONIC DISSECTOR
K141371
Covidien, Formerly Valleylab, A Division of Tyco H
General & Plastic Surgery · 72d
Cleared Dec 16, 2013
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
K132522
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 126d
Cleared Dec 03, 2013
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
K133314
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 36d
Cleared Oct 24, 2013
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
K132512
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 73d
Cleared Oct 17, 2013
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE
K132612
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 57d
Cleared Mar 20, 2013
TX1 TISSUE REMOVAL SYSTEM
K123640
Tenex Health
General & Plastic Surgery · 114d
Cleared Aug 22, 2012
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY
K121550
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 89d
Cleared May 17, 2012
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23
K120729
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 69d
Cleared Feb 22, 2012
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
K113570
Integra Burlington Ma, Inc.
General & Plastic Surgery · 82d
Cleared Aug 23, 2011
INTEGRA(TM) CUSA NXT(TM) BONE TIPS
K111741
Integra Burlington Ma, Inc. (Formerly Integra Radi
General & Plastic Surgery · 63d
Cleared Jun 10, 2011
CUSA NXT EXTENDED LENGTH TIP
K102258
Integra Radionics, Inc.
General & Plastic Surgery · 304d
Cleared Feb 24, 2011
SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T
K101797
Covidien, Formerly Valleylab, A Division of Tyco
General & Plastic Surgery · 241d
Cleared Aug 27, 2010
TX1 TISSUE REMOVAL SYSTEM
K101561
American Optisurgical, Inc.
General & Plastic Surgery · 84d
Cleared Apr 07, 2010
HARMONIC FOCUS SHEARS
K100597
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 36d
Cleared May 08, 2009
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K090864
Integra Radionics, Inc.
General & Plastic Surgery · 39d
Cleared Aug 13, 2008
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
K081459
Integra Radionics, Inc.
General & Plastic Surgery · 82d
Cleared May 21, 2008
SONOCA 180/195 WOUND CARE SYSTEM
K072904
Soering GmbH
General & Plastic Surgery · 223d
Cleared Sep 25, 2007
HARMONIC 10CM COMBINATION HOOK BLADE
K072203
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 48d
Cleared Aug 17, 2007
INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP
K071669
Integra Radionics, Inc.
General & Plastic Surgery · 59d
Cleared Aug 07, 2007
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
K070360
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 181d
Cleared May 11, 2007
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K070313
Misonix, Inc.
General & Plastic Surgery · 99d