Cleared Special

K132512 - HARMONIC ACE CURVED SHEARS WITH SCISSOR...

K132512 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
73d
Days
-
Risk

K132512 is an FDA 510(k) clearance for the HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WI.... Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on October 24, 2013 after a review of 73 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K132512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2013
Decision Date October 24, 2013
Days to Decision 73 days
Submission Type Special
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
42d faster than avg
Panel avg: 115d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 78
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K120729 · Ethicon Endo-Surgery, LLC · May 2012