Cleared Traditional

K140533 - GALAFLEX MESH
(FDA 510(k) Clearance)

K140533 · Tepha, Inc. · General & Plastic Surgery
May 2014
Decision
78d
Days
Class 2
Risk

K140533 is an FDA 510(k) clearance for the GALAFLEX MESH. This device is classified as a Surgical Film (Class II — Special Controls, product code OOD).

Submitted by Tepha, Inc. (Lexington, US). The FDA issued a Cleared decision on May 21, 2014, 78 days after receiving the submission on March 4, 2014.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. To Be Implanted To Reinforce Soft Tissue Or Bone Where Weakness Exists. Intended To Be Used Wherever Temporary Wound Support Is Required, To Reinforce Soft Tissues Where Weakness Exists In The Urological, Gynecological, Or Gastrointestinal Anatomy, Or For The Repair Of Hernia Or Other Fascial Defects That Require The Addition Of A Reinforcing Or Bridging Material To Obtain The Desired Surgical Result. The Absorbable Protective Film Also May Help Minimize The Potential For Tissue Attachment To The Device In Case Of Direct Contact With The Viscera..

Submission Details

510(k) Number K140533 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2014
Decision Date May 21, 2014
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OOD — Surgical Film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition To Be Implanted To Reinforce Soft Tissue Or Bone Where Weakness Exists. Intended To Be Used Wherever Temporary Wound Support Is Required, To Reinforce Soft Tissues Where Weakness Exists In The Urological, Gynecological, Or Gastrointestinal Anatomy, Or For The Repair Of Hernia Or Other Fascial Defects That Require The Addition Of A Reinforcing Or Bridging Material To Obtain The Desired Surgical Result. The Absorbable Protective Film Also May Help Minimize The Potential For Tissue Attachment To The Device In Case Of Direct Contact With The Viscera.