Cleared Traditional

K182588 - Medline ReNewal Reprocessed LigaSure Ma...

K182588 is an FDA 510(k) clearance for Medline ReNewal Reprocessed LigaSure Ma..., 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 41-day FDA review.

K182588 · 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
Oct 2018
Decision
41d
Days
Class 2
Risk

K182588 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed LigaSure Maryland Jaw 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 October 31, 2018 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgical Instrument Service and Savings Inc.(Dba Medline Ren devices

FDA 510(k) Submission Details - K182588

510(k) Number K182588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2018
Decision Date October 31, 2018
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
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 29
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