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, Ethicon Endo-Surgery, LLC and Stryker Corporation.

12
Total
12
Cleared
101d
Avg days
2021
Since

List of Instrument, Ultrasonic Surgical devices cleared through 510(k)

12 devices
1–12 of 12
Cleared Oct 08, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162
Integra LifeSciences Corporation
General & Plastic Surgery · 176d
Cleared Mar 24, 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930
Stryker Instruments
General & Plastic Surgery · 94d
Cleared Jul 11, 2024
CUSA® Clarity Ultrasonic Surgical Aspirator System
K240493
Integra LifeSciences Corporation
Obstetrics & Gynecology · 142d
Cleared Jul 11, 2023
CUSA Clarity Ultrasonic Surgical Aspirator System
K230427
Integra LifeSciences Corporation
General & Plastic Surgery · 144d
Cleared Feb 28, 2023
HARMONIC 700 Shears
K221790
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 252d
Cleared Feb 16, 2023
Sonopet 1Q 3 7cm 1Q Large
K223770
Stryker Corporation
General & Plastic Surgery · 63d
Cleared Aug 22, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221835
Integra LifeSciences Corporation
General & Plastic Surgery · 60d
Cleared Jul 15, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221763
Integra LifeSciences Corporation
General & Plastic Surgery · 28d
Cleared Feb 03, 2022
Sonopet iQ Ultrasonic Aspirator System
K213824
Stryker Corporation
General & Plastic Surgery · 57d
Cleared Nov 15, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301
Covidien, LLC
General & Plastic Surgery · 115d
Cleared Aug 04, 2021
Ultrasonic Bipolar Generator USG-410 with accessories
K211838
Olympus Medical Systems Corporation
General & Plastic Surgery · 51d
Cleared May 21, 2021
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
K211273
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 24d

How to use this database

This page lists all FDA 510(k) submissions for Instrument, Ultrasonic Surgical devices (product code LFL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →