Cleared Traditional

K120729 - HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23

K120729 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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 TEC.... Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on May 17, 2012 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K120729

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 157
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K120729.
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE
K132612 · Ethicon Endo-Surgery, LLC · Oct 2013
TX1 TISSUE REMOVAL SYSTEM
K123640 · Tenex Health · Mar 2013
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY
K121550 · Ethicon Endo-Surgery, LLC · Aug 2012
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
K113570 · Integra Burlington Ma, Inc. · Feb 2012
INTEGRA(TM) CUSA NXT(TM) BONE TIPS
K111741 · Integra Burlington Ma, Inc. (Formerly Integra Radi · Aug 2011
CUSA NXT EXTENDED LENGTH TIP
K102258 · Integra Radionics, Inc. · Jun 2011
K120729 · HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23
Download PDF FDA Summary Ethicon Endo-Surgery,…