Cleared Special

VOLISTA 400; VOLISTA 600

K130513 · Maquet S.A.S. · General & Plastic Surgery
May 2013
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K130513 is an FDA 510(k) clearance for the VOLISTA 400; VOLISTA 600, a Lamp, Surgical (Class II — Special Controls, product code FTD), submitted by Maquet S.A.S. (Wayne, US). The FDA issued a Cleared decision on May 8, 2013, 70 days after receiving the submission on February 27, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K130513 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2013
Decision Date May 08, 2013
Days to Decision 70 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTD — Lamp, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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