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 Integra LifeSciences Corporation, Covidien, LLC and Stryker Corporation.

157
Total
157
Cleared
123d
Avg days
1980
Since
157 devices
25–48 of 157
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 Jul 01, 1997
ULTRASONIC HAND INSTRUMENTS
K971861
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 42d
Cleared Jun 16, 1983
NEEDLE GUIDE MODEL 21285A
K830753
Hewlett-Packard Co.
General & Plastic Surgery · 98d