Cleared Traditional

K232511 - Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)

K232511 is an FDA 510(k) clearance for Medline ReNewal Reprocessed LigaSure Ex..., manufactured by Surgical Instrument Service 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 255-day FDA review.

K232511 · Surgical Instrument Service and Savings, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
255d
Days
Class 2
Risk

K232511 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019). 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 April 29, 2024 after a review of 255 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

FDA 510(k) Submission Details - K232511

510(k) Number K232511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2023
Decision Date April 29, 2024
Days to Decision 255 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
140d slower than avg
Panel avg: 115d · This submission: 255d
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 32
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K232511.
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
K230251 · Stryker Sustainability Solutions · Mar 2023
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
K220411 · Stryker Sustainability Solutions · May 2022
Green OR Reprocessed Aquamantys Bipolar Sealer
K211203 · Green Or, LLC · Apr 2022
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
K191073 · Vein 360, LLC · Oct 2019
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
K182588 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · Oct 2018
Reprocessed LigaSure Maryland Jaw Sealer/Divider
K180499 · Stryker Sustainability Solutions · Apr 2018