Cleared Traditional

K955664 - STERILIZED TRI BLOCK POLYMER GEL SHEET

K955664 is an FDA 510(k) clearance for STERILIZED TRI BLOCK POLYMER GEL SHEET, manufactured by Silipos, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K955664 · Silipos, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
77d
Days
Class 1
Risk

K955664 is an FDA 510(k) clearance for the STERILIZED TRI BLOCK POLYMER GEL SHEET. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Silipos, Inc. (New York, US). The FDA issued a Cleared decision on February 28, 1996 after a review of 77 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 Silipos, Inc. devices

FDA 510(k) Submission Details - K955664

510(k) Number K955664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1995
Decision Date February 28, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
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 51
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K955664.
DURASIL (MODIFICATION)
K961410 · The S. F. Group, Inc. · Sep 1996
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996
SILGEL TOPICAL GEL SHEET
K960254 · Rofil Medical USA, Inc. · Apr 1996
SKIN NEUVEAU SCAR TREATMENT
K942339 · Puritas Health Care, Inc. · Nov 1994
SILK*SKIN SCAR TREATMENT
K941197 · Puritas Health Care, Inc. · Aug 1994
NOVAGEL SILICONE GEL SHEETING
K941125 · Brennen Medical, Inc. · May 1994