Cleared Traditional

K153745 - Medline ReNewal Reprocessed LigaSure Im...

K153745 is an FDA 510(k) clearance for Medline ReNewal Reprocessed LigaSure Im..., manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The device is a Class 2 General & Plastic Surgery device with product code NUJ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K153745 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
125d
Days
Class 2
Risk

K153745 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider. Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Surgical Instrument Service and Savings Inc.(Dba Medline Ren (Redmond, US). The FDA issued a Cleared decision on May 2, 2016 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. 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 Service and Savings Inc.(Dba Medline Ren devices

FDA 510(k) Submission Details - K153745

510(k) Number K153745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2015
Decision Date May 02, 2016
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUJ Device Classification - Class 2, Special Controls

Product Code NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

All 28
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K153745.
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
K171324 · Surgical Instrument Service and Savings, Inc. · Jun 2017
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
K161086 · Sterilmed, Inc. · Sep 2016
Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
K160333 · Surgical Instrument Service and Savings, Inc. · Jul 2016
Reprocessed Vessel Sealer
K152134 · Sterilmed, Inc. · Jan 2016
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
K150538 · Stryker Sustainability Solutions · Jun 2015
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
K143260 · Sterilmed, Inc. · Feb 2015