Cleared Traditional

K133672 - REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY

K133672 · Stryker Sustainability Solutions · General & Plastic Surgery device
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May 2014
Decision
153d
Days
-
Risk

K133672 is an FDA 510(k) clearance for the REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY. Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on May 1, 2014 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K133672

510(k) Number K133672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2013
Decision Date May 01, 2014
Days to Decision 153 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
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

NLQ Device Classification - Class 0,

Product Code NLQ Single-use Reprocessed Ultrasonic Surgical Instruments
Device Class -
Definition Single-use Reprocessed Versions Of The Ultrasonic Devices Used In Surgical Procedures Either For Fragmentation, Emulsification And Aspiration Of Soft Tissue And Hard Tissue Or For Ligation Of Vessels (under Product Code “lfl”). Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission.. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).

Regulatory Peers - NLQ Single-use Reprocessed Ultrasonic Surgical Instruments

All 25
Devices cleared under the same product code (NLQ) and FDA review panel - the closest regulatory comparables to K133672.
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
K150524 · Surgical Instrument Services and Savings, Inc. · Dec 2015
Reprocessed Cordless Ultrasonic Dissection Device
K143562 · Sterilmed, Inc. · May 2015
REPROCESSED HARMONIC SHEAR
K132566 · Sterilmed, Inc. · Jun 2014
MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
K124033 · Surgical Instruments Service and Savings, Inc. · Jan 2014
REPROCESSED HARMONIC SCALPEL
K111794 · Sterilmed, Inc. · Jan 2012
REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
K100537 · Ascent Healthcare Solutions · May 2010