Cleared Traditional

K162751 - Medline ReNewal Reprocessed Ligasure Curved

K162751 is an FDA 510(k) clearance for Medline ReNewal Reprocessed Ligasure Curved, manufactured by Surgical Instrument Services and Savings, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NUJ cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K162751 · Surgical Instrument Services and Savings, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
213d
Days
Class 2
Risk

K162751 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider. Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Surgical Instrument Services and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on May 1, 2017 after a review of 213 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 Services and Savings, Inc. devices

FDA 510(k) Submission Details - K162751

510(k) Number K162751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date May 01, 2017
Days to Decision 213 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
98d slower than avg
Panel avg: 115d · This submission: 213d
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 K162751.
Reprocessed ArthroCare ENT Coblator
K172647 · Renovo, Inc. · Feb 2018
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
K172608 · Surgical Instrument Service and Savings, Inc. · Oct 2017
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