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
Jun 11, 1991
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
Valleylab, Inc.
General & Plastic Surgery
112d
Cleared
Nov 21, 1990
SURGICAL ASPIRATOR KIT
Surgeon Surgical Instrumentation, Inc.
General & Plastic Surgery
84d
Cleared
Sep 05, 1990
SELECTOR ULTRASONIC SURGICAL ASPIRATOR
Spembly Medical , Ltd.
General & Plastic Surgery
127d
Cleared
Jul 03, 1990
SONOCA II ULTRASONIC SURGICAL DEVICE
Holl Meditronics, Inc.
General & Plastic Surgery
77d
Cleared
Jan 19, 1990
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
Valleylab, Inc.
General & Plastic Surgery
183d
Cleared
Nov 14, 1989
SONOCA ULTRASONIC SURGICAL SYSTEM
Holl Meditronics, Inc.
General & Plastic Surgery
167d
Cleared
Oct 14, 1988
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
Sharplan Lasers, Inc.
General & Plastic Surgery
84d
Cleared
Apr 13, 1988
DX101 ULTRASONIC SURGICAL SYSTEM
Niic U.S.A., Inc.
General & Plastic Surgery
56d
Cleared
Apr 13, 1988
DX101-T ULTRASONIC SURGICAL SYSTEM
Niic U.S.A., Inc.
General & Plastic Surgery
56d
Cleared
Feb 18, 1988
BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
Clinical Technology Corp.
General & Plastic Surgery
35d
Cleared
Jun 23, 1987
CUSA SYSTEM 200 MACRO-DISSECTOR
Cooper Lasersonics, Inc.
General & Plastic Surgery
183d
Cleared
Jul 23, 1985
R PAK
CooperVision, Inc.
General & Plastic Surgery
119d
Cleared
Jul 23, 1985
SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery
39d
Cleared
Jun 16, 1983
NEEDLE GUIDE MODEL 21285A
Hewlett-Packard Co.
General & Plastic Surgery
98d
Cleared
Jul 13, 1982
MCSC6PS MEDICAL COMPONENTS
Medical Components, Inc.
General & Plastic Surgery
22d
Cleared
Nov 18, 1980
CAVITRON ULTRASONIC SURG. ASPIR. CUSA
Cavitron Corp.
General & Plastic Surgery
126d