Cleared Traditional

K161092 - GalaSHAPE 3D (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161092 · Tepha, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
127d
Days
Class 2
Risk

K161092 is an FDA 510(k) clearance for the GalaSHAPE 3D. Classified as Surgical Film (product code OOD), Class II - Special Controls.

Submitted by Tepha, Inc. (Lexington, US). The FDA issued a Cleared decision on August 23, 2016 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Tepha, Inc. devices

Submission Details

510(k) Number K161092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2016
Decision Date August 23, 2016
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 114d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OOD Surgical Film
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.