Cleared Traditional

K964846 - IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING

K964846 is an FDA 510(k) clearance for IMPLATECH RP MEDICAL GRADE SILICONE GEL..., manufactured by Implantech Associates, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K964846 · Implantech Associates, Inc. · General & Plastic Surgery device
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Feb 1997
Decision
71d
Days
Class 1
Risk

K964846 is an FDA 510(k) clearance for the IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on February 12, 1997 after a review of 71 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 Implantech Associates, Inc. devices

FDA 510(k) Submission Details - K964846

510(k) Number K964846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date February 12, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
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 K964846.
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
NOVAGEL SILICONE GEL SHEETING
K963128 · Brennen Medical, Inc. · Dec 1996
DURASIL (MODIFICATION)
K961410 · The S. F. Group, Inc. · Sep 1996
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996