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
Cleared
Jul 10, 2020
Sonicision Cordless Ultrasonic Dissector
Covidien, LLC
General & Plastic Surgery
140d
Cleared
Jun 23, 2020
CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
Neurology
90d
Cleared
Jun 19, 2020
Kogent Torus Ultrasonic Aspirator
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
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
261d
Cleared
Oct 31, 2019
Ultrasonic Surgical System
Medisonic Technology CO
General & Plastic Surgery
262d
Cleared
May 30, 2019
neXus Ultrasonic Surgical Aspirator System
Misonix, Inc.
General & Plastic Surgery
120d
Cleared
Apr 11, 2019
Sonopet iQ Ultrasonic Aspirator System
Stryker Corporation
General & Plastic Surgery
86d
Cleared
Apr 01, 2019
CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
General & Plastic Surgery
59d
Cleared
Dec 07, 2018
CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
General & Plastic Surgery
65d
Cleared
Aug 28, 2018
Tenex Health TX System with the TXP MicroTip
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
Covidien, LLC
General & Plastic Surgery
66d
Cleared
Oct 04, 2017
Ultrasonic Generator
Olympus Medical Systems Corp.
General & Plastic Surgery
28d
Cleared
Jul 01, 1997
ULTRASONIC HAND INSTRUMENTS
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
42d
Cleared
Jun 16, 1983
NEEDLE GUIDE MODEL 21285A
Hewlett-Packard Co.
General & Plastic Surgery
98d