Cleared Traditional

K143562 - Reprocessed Cordless Ultrasonic Dissection Device

K143562 · Sterilmed, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2015
Decision
155d
Days
-
Risk

K143562 is an FDA 510(k) clearance for the Reprocessed Cordless Ultrasonic Dissection Device. 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 May 20, 2015 after a review of 155 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 Sterilmed, Inc. devices

FDA 510(k) Submission Details - K143562

510(k) Number K143562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2014
Decision Date May 20, 2015
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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 Consultant

Libra Medical
JULIE BODMER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K143562.
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
K161693 · Stryker Sustainability Solutions · Feb 2017
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 HARMONIC SHEAR
K132566 · Sterilmed, Inc. · Jun 2014
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