Cleared Traditional

K971916 - MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL

K971916 is an FDA 510(k) clearance for MEDICAL Z, manufactured by Medical Z, S.A.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K971916 · Medical Z, S.A. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
67d
Days
Class 1
Risk

K971916 is an FDA 510(k) clearance for the MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Medical Z, S.A. (Washington, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Z, S.A. devices

FDA 510(k) Submission Details - K971916

510(k) Number K971916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date July 29, 1997
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 53
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K971916.
KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
K973572 · Hanson Medical, Inc. · Oct 1997
PMT NEW BEGINNINGS GELSHAPES & AMEND
K972597 · Pmt Corp. · Oct 1997
SCAR CARE
K971009 · Target Health, Inc. · Jul 1997
DEGANIA SILICONE SIL-K
K971482 · Degania Silicone , Ltd. · Jun 1997
SCAR HEAL
K971468 · Specialty Systems, Inc. · Jun 1997
SPECTRUM DESIGNS SPECTRAGEL
K970702 · Spectrum Designs, Inc. · May 1997