Cleared Special

K230251 - Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

K230251 is an FDA 510(k) clearance for Reprocessed LigaSure Curved, manufactured by Stryker Sustainability Solutions. The device is a Class 2 General & Plastic Surgery device with product code NUJ cleared through the Special 510(k) pathway after a 57-day FDA review.

K230251 · Stryker Sustainability Solutions · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
57d
Days
Class 2
Risk

K230251 is an FDA 510(k) clearance for the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A). 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 March 28, 2023 after a review of 57 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K230251

510(k) Number K230251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2023
Decision Date March 28, 2023
Days to Decision 57 days
Submission Type Special
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
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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 36
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K230251.
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
K232511 · Surgical Instrument Service and Savings, Inc. · Apr 2024
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
K230251 · Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
Download PDF FDA Summary Stryker Sustainabilit…