Cleared Traditional

K180451 - Reprocessed LigaSure Impact without Nan...

K180451 is the FDA 510(k) clearance for Reprocessed LigaSure Impact without Nan... by Stryker Sustainability Solutions. It is a Class 2 General & Plastic Surgery device (product code NUJ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K180451 · Stryker Sustainability Solutions · General & Plastic Surgery device
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Apr 2018
Decision
59d
Days
Class 2
Risk

K180451 is an FDA 510(k) clearance for the Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider. Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on April 20, 2018 after a review of 59 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 Stryker Sustainability Solutions devices

Submission Details

510(k) Number K180451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2018
Decision Date April 20, 2018
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
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 20
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K180451.
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
NES Reprocessed RF Stylet (RFS)
K173214 · Northeast Scientific, Inc. (Nes) · Mar 2018
Reprocessed DePuy Mitek Ablation Wand
K173740 · Renovo, Inc. · Mar 2018
Reprocessed ArthoCare Ablation Wand
K173741 · Renovo, Inc. · Mar 2018