Cleared Traditional

K160333 - Medline ReNewal Reprocessed LigaSure Bl...

K160333 is the FDA 510(k) clearance for Medline ReNewal Reprocessed LigaSure Bl... by Surgical Instrument Service and Savings, Inc.. It is a Class 2 General & Plastic Surgery device (product code NUJ) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K160333 · Surgical Instrument Service and Savings, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
163d
Days
Class 2
Risk

K160333 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed LigaSure Blunt Tip 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. (Redmond, US). The FDA issued a Cleared decision on July 20, 2016 after a review of 163 days - an extended review cycle.

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. devices

Submission Details

510(k) Number K160333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date July 20, 2016
Days to Decision 163 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
48d slower than avg
Panel avg: 115d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K160333.
Reprocessed ArthoCare Ablation Wand
K173741 · Renovo, Inc. · Mar 2018
Reprocessed ArthroCare ENT Coblator
K172647 · Renovo, Inc. · Feb 2018
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
K161086 · Sterilmed, Inc. · Sep 2016
Reprocessed Vessel Sealer
K152134 · Sterilmed, Inc. · Jan 2016
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
K143260 · Sterilmed, Inc. · Feb 2015
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
K131614 · Covidien · Aug 2013