Cleared Traditional

K120729 - HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 (FDA 510(k) Clearance)

May 2012
Decision
69d
Days
Risk

K120729 is an FDA 510(k) clearance for the HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on May 17, 2012, 69 days after receiving the submission on March 9, 2012.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K120729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2012
Decision Date May 17, 2012
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

Similar Devices — LFL Instrument, Ultrasonic Surgical

All 12
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162 · Integra LifeSciences Corporation · Oct 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · Stryker Instruments · Mar 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
K240493 · Integra LifeSciences Corporation · Jul 2024
CUSA Clarity Ultrasonic Surgical Aspirator System
K230427 · Integra LifeSciences Corporation · Jul 2023
HARMONIC 700 Shears
K221790 · Ethicon Endo-Surgery, LLC · Feb 2023
Sonopet 1Q 3 7cm 1Q Large
K223770 · Stryker Corporation · Feb 2023