Cleared Traditional

K150524 - Medline ReNewal Reprocessed Harmonic FO...

K150524 · Surgical Instrument Services and Savings, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
289d
Days
-
Risk

K150524 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Te.... Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Surgical Instrument Services and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on December 16, 2015 after a review of 289 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.

View all Surgical Instrument Services and Savings, Inc. devices

FDA 510(k) Submission Details - K150524

510(k) Number K150524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2015
Decision Date December 16, 2015
Days to Decision 289 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
174d slower than avg
Panel avg: 115d · This submission: 289d
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 20
Devices cleared under the same product code (NLQ) and FDA review panel - the closest regulatory comparables to K150524.
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
K173627 · Surgical Instrument Service and Savings, Inc. · Jul 2018
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K170456 · Stryker Sustainability Solutions · Apr 2017
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
K161693 · Stryker Sustainability Solutions · Feb 2017
Reprocessed Cordless Ultrasonic Dissection Device
K143562 · Sterilmed, Inc. · May 2015
REPROCESSED HARMONIC SHEAR
K132566 · Sterilmed, Inc. · Jun 2014
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
K133672 · Stryker Sustainability Solutions · May 2014