Cleared Traditional

Medline General Surgery Tray

K213481 · Medline Industries, Inc. · General & Plastic Surgery

May 2022

Decision

207d

Days

Class 2

Risk

About This 510(k) Submission

K213481 is an FDA 510(k) clearance for the Medline General Surgery Tray, a General Surgery Tray (Class II — Special Controls, product code LRO), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on May 24, 2022, 207 days after receiving the submission on October 29, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K213481 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 2021
Decision Date	May 24, 2022
Days to Decision	207 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	LRO — General Surgery Tray
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4370
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance