Cleared Special

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

K230251 · Stryker Sustainability Solutions · General & Plastic Surgery
Mar 2023
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K230251 is an FDA 510(k) clearance for the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A), a Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (Class II — Special Controls, product code NUJ), submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on March 28, 2023, 57 days after receiving the submission on January 30, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K230251 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NUJ — Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class Class II — 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).

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