Cleared Traditional

LiquiBand Exceed

K151182 · Advanced Medical Solutions (Plymouth), Ltd. · General & Plastic Surgery
Oct 2015
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K151182 is an FDA 510(k) clearance for the LiquiBand Exceed, a Tissue Adhesive For The Topical Approximation Of Skin (Class II — Special Controls, product code MPN), submitted by Advanced Medical Solutions (Plymouth), Ltd. (Plymouth, GB). The FDA issued a Cleared decision on October 26, 2015, 175 days after receiving the submission on May 4, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4010.

Submission Details

510(k) Number K151182 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2015
Decision Date October 26, 2015
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MPN — Tissue Adhesive For The Topical Approximation Of Skin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4010
Definition Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).

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