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.

158
Total
158
Cleared
123d
Avg days
1980
Since
158 devices
49–72 of 158
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 Apr 07, 2010
HARMONIC FOCUS SHEARS
K100597
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 36d
Cleared Sep 25, 2007
HARMONIC 10CM COMBINATION HOOK BLADE
K072203
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 48d
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
Cleared Jan 30, 2007
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP
K063192
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 102d
Cleared Oct 26, 2006
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
K062471
Misonix, Inc.
General & Plastic Surgery · 63d
Cleared Sep 25, 2006
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S
K062000
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 70d
Cleared Apr 07, 2006
HARMONIC SCALPEL BLADES AND SHEARS
K060245
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 66d
Cleared Jan 19, 2006
HARMONIC SCALPEL BLADES AND SHEARS
K053056
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 80d
Cleared Jun 06, 2005
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K050776
Misonix, Inc.
General & Plastic Surgery · 70d
Cleared Jun 03, 2005
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG
K050885
Olympus Medical Systems Corporation
General & Plastic Surgery · 57d
Cleared Jun 02, 2005
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
K051036
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 38d
Cleared Jan 25, 2005
SONOSURG TROCAR
K042160
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 168d