Cleared Traditional

K132566 - REPROCESSED HARMONIC SHEAR

K132566 · Sterilmed, Inc. · General & Plastic Surgery device
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Jun 2014
Decision
303d
Days
-
Risk

K132566 is an FDA 510(k) clearance for the REPROCESSED HARMONIC SHEAR. Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 14, 2014 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sterilmed, Inc. devices

FDA 510(k) Submission Details - K132566

510(k) Number K132566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2013
Decision Date June 14, 2014
Days to Decision 303 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
188d slower than avg
Panel avg: 115d · This submission: 303d
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 K132566.
Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
K151405 · Surgical Instrument Services and Savings(Dba Medline Renewal · Jan 2016
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 ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
K133672 · Stryker Sustainability Solutions · May 2014
MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
K124033 · Surgical Instruments Service and Savings, Inc. · Jan 2014
REPROCESSED HARMONIC SCALPEL
K111794 · Sterilmed, Inc. · Jan 2012