Cleared Traditional

K141127 - MEDLINE ANTI-EMBOLISM STOCKING
(FDA 510(k) Clearance)

K141127 · Medline Industries, Inc. · General Hospital

Aug 2014

Decision

112d

Days

Class 2

Risk

K141127 is an FDA 510(k) clearance for the MEDLINE ANTI-EMBOLISM STOCKING, a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II — Special Controls, product code DWL), submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on August 21, 2014, 112 days after receiving the submission on May 1, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5780.

Submission Details

510(k) Number	K141127 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2014
Decision Date	August 21, 2014
Days to Decision	112 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	DWL — Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5780