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
Cleared
May 29, 2015
Prime Adaptive Ultrasonic Scalpel System
Endoprime, Inc.
General & Plastic Surgery
114d
Cleared
Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Integra LifeSciences Corporation
General & Plastic Surgery
136d
Cleared
Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Integra LifeSciences Corporation
General & Plastic Surgery
136d
Cleared
Aug 07, 2014
SONICISION CORDLESS ULTRASONIC DISSECTOR
Covidien, Formerly Valleylab, A Division of Tyco H
General & Plastic Surgery
72d
Cleared
Dec 16, 2013
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
126d
Cleared
Dec 03, 2013
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
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
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
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
57d
Cleared
Mar 20, 2013
TX1 TISSUE REMOVAL SYSTEM
Tenex Health
General & Plastic Surgery
114d
Cleared
Aug 22, 2012
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY
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
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
69d
Cleared
Feb 22, 2012
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
Integra Burlington Ma, Inc.
General & Plastic Surgery
82d
Cleared
Aug 23, 2011
INTEGRA(TM) CUSA NXT(TM) BONE TIPS
Integra Burlington Ma, Inc. (Formerly Integra Radi
General & Plastic Surgery
63d
Cleared
Jun 10, 2011
CUSA NXT EXTENDED LENGTH TIP
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
Covidien, Formerly Valleylab, A Division of Tyco
General & Plastic Surgery
241d
Cleared
Aug 27, 2010
TX1 TISSUE REMOVAL SYSTEM
American Optisurgical, Inc.
General & Plastic Surgery
84d
Cleared
Apr 07, 2010
HARMONIC FOCUS SHEARS
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
Integra Radionics, Inc.
General & Plastic Surgery
39d
Cleared
Aug 13, 2008
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
Integra Radionics, Inc.
General & Plastic Surgery
82d
Cleared
May 21, 2008
SONOCA 180/195 WOUND CARE SYSTEM
Soering GmbH
General & Plastic Surgery
223d
Cleared
Sep 25, 2007
HARMONIC 10CM COMBINATION HOOK BLADE
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
48d
Cleared
Aug 17, 2007
INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP
Integra Radionics, Inc.
General & Plastic Surgery
59d
Cleared
Aug 07, 2007
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
Kirwan Surgical Products, Inc.
General & Plastic Surgery
181d
Cleared
May 11, 2007
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Misonix, Inc.
General & Plastic Surgery
99d