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
Cleared
Nov 04, 1996
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
126d
Cleared
Apr 29, 1996
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
Sharplan Lasers, Inc.
General & Plastic Surgery
118d
Cleared
Jul 11, 1995
CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS
Valleylab, Inc.
General & Plastic Surgery
664d
Cleared
Apr 10, 1995
COOPER LASER SONICS CUSA MODEL 200
Valleylab, Inc.
General & Plastic Surgery
82d
Cleared
Sep 16, 1994
CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.
Valleylab, Inc.
General & Plastic Surgery
515d
Cleared
Oct 12, 1993
CV720-727-000, MICROTIP AND FLUE PAK
Valleylab, Inc.
General & Plastic Surgery
102d
Cleared
Jun 12, 1992
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR
Valleylab, Inc.
General & Plastic Surgery
88d
Cleared
Jun 11, 1991
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
Valleylab, Inc.
General & Plastic Surgery
112d
Cleared
Jan 19, 1990
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
Valleylab, Inc.
General & Plastic Surgery
183d
Cleared
Oct 14, 1988
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
Sharplan Lasers, Inc.
General & Plastic Surgery
84d
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