Cleared Traditional

LiquiBand XL

K211878 · Advanced Medical Solutions Limited · General & Plastic Surgery

May 2022

Decision

336d

Days

Class 2

Risk

About This 510(k) Submission

K211878 is an FDA 510(k) clearance for the LiquiBand XL, a Cutaneous Tissue Adhesive With Mesh (Class II — Special Controls, product code OMD), submitted by Advanced Medical Solutions Limited (Plymouth, GB). The FDA issued a Cleared decision on May 23, 2022, 336 days after receiving the submission on June 21, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4011.

Submission Details

510(k) Number	K211878 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2021
Decision Date	May 23, 2022
Days to Decision	336 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OMD — Cutaneous Tissue Adhesive With Mesh
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4011
Definition	For Topical Application Only To Hold Closed Easily Approximated Skin Edges Of Wounds Such As Wounds From Surgical Incisions, Including Punctures From Minimally Invasive Surgery, And Simple Thorough Cleansed, Trauma-induced Lacerations. The Device May Be Used In Conjunction With, But Not In Place Of, Deep Dermal Sutures.