Cleared Traditional

K161693 - Reprocessed HARMONIC ACE+7

K161693 · Stryker Sustainability Solutions · General & Plastic Surgery device
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Feb 2017
Decision
248d
Days
-
Risk

K161693 is an FDA 510(k) clearance for the Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis. 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 February 23, 2017 after a review of 248 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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Submission Details

510(k) Number K161693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2016
Decision Date February 23, 2017
Days to Decision 248 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 115d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 15
Devices cleared under the same product code (NLQ) and FDA review panel - the closest regulatory comparables to K161693.
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K190610 · Sterilmed, Inc. · Aug 2019
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
K182272 · Sterilmed, Inc. · Apr 2019
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
K173627 · Surgical Instrument Service and Savings, Inc. · Jul 2018
Reprocessed Cordless Ultrasonic Dissection Device
K143562 · Sterilmed, Inc. · May 2015
REPROCESSED HARMONIC SHEAR
K132566 · Sterilmed, Inc. · Jun 2014
REPROCESSED HARMONIC SCALPEL
K111794 · Sterilmed, Inc. · Jan 2012