Cleared Traditional

MEDLINE SURGICAL SPONGE SCANNER

K061316 · Medline Industries, Inc. · General & Plastic Surgery
Nov 2006
Decision
175d
Days
Class 1
Risk

About This 510(k) Submission

K061316 is an FDA 510(k) clearance for the MEDLINE SURGICAL SPONGE SCANNER, a Counter, Sponge, Surgical (Class I — General Controls, product code LWH), submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 2, 2006, 175 days after receiving the submission on May 11, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2740.

Submission Details

510(k) Number K061316 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2006
Decision Date November 02, 2006
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LWH — Counter, Sponge, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.2740

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