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
25–48 of 158
Cleared Jul 10, 2020
Sonicision Cordless Ultrasonic Dissector
K200427
Covidien, LLC
General & Plastic Surgery · 140d
Cleared Jun 23, 2020
CUSA Clarity Ultrasonic Surgical Aspirator System
K200774
Integra LifeSciences Corporation
Neurology · 90d
Cleared Jun 19, 2020
Kogent Torus Ultrasonic Aspirator
K192963
Katalyst Surgical, LLC
General & Plastic Surgery · 240d
Cleared Feb 28, 2020
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
K191555
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 261d
Cleared Oct 31, 2019
Ultrasonic Surgical System
K190281
Medisonic Technology CO
General & Plastic Surgery · 262d
Cleared May 30, 2019
neXus Ultrasonic Surgical Aspirator System
K190160
Misonix, Inc.
General & Plastic Surgery · 120d
Cleared Apr 11, 2019
Sonopet iQ Ultrasonic Aspirator System
K190070
Stryker Corporation
General & Plastic Surgery · 86d
Cleared Apr 01, 2019
CUSA Clarity Ultrasonic Surgical Aspirator System
K190180
Integra LifeSciences Corporation
General & Plastic Surgery · 59d
Cleared Dec 07, 2018
CUSA Clarity Ultrasonic Surgical Aspirator System
K182809
Integra LifeSciences Corporation
General & Plastic Surgery · 65d
Cleared Aug 28, 2018
Tenex Health TX System with the TXP MicroTip
K181367
Tenex Health, Inc.
General & Plastic Surgery · 97d
Cleared Mar 26, 2018
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
K180149
Covidien, LLC
General & Plastic Surgery · 66d
Cleared Oct 04, 2017
Ultrasonic Generator
K172691
Olympus Medical Systems Corp.
General & Plastic Surgery · 28d
Cleared Sep 28, 2017
CUSA Excel+ Ultrasonic Surgical Aspirator System
K172595
Integra LifeSciences Corporation
General & Plastic Surgery · 30d
Cleared Oct 14, 2016
CUSA Clarity Ultrasonic Surgical Aspirator System
K161882
Integra LifeSciences Corporation
General & Plastic Surgery · 95d
Cleared Mar 28, 2016
Sonicision Cordless Ultrasonic Dissection Device
K153371
Covidien, LLC
General & Plastic Surgery · 126d
Cleared Mar 04, 2016
HARMONIC HOOK
K151136
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 310d
Cleared Jul 10, 2015
HARMONIC Focus Long Shears + Adaptive Tissue Technology
K151340
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 52d
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 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 Aug 22, 2012
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY
K121550
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 89d