Cleared Traditional

K972914 - SYVEK PATCH

K972914 is an FDA 510(k) clearance for SYVEK PATCH, manufactured by Marine Polymer Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K972914 · Marine Polymer Technologies, Inc. · General & Plastic Surgery device
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Dec 1997
Decision
137d
Days
Class 1
Risk

K972914 is an FDA 510(k) clearance for the SYVEK PATCH. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on December 22, 1997 after a review of 137 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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.

FDA 510(k) Submission Details - K972914

510(k) Number K972914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1997
Decision Date December 22, 1997
Days to Decision 137 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
22d slower than avg
Panel avg: 115d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 109
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K972914.
SERAGARD INJECTION PATCH
K001240 · Platinum Services, Inc. · Jun 2000
CARE BAND ANTIBACTERIAL BANDAGES
K983368 · Aso Corp. · Feb 1999
ADHESIVE BANDAGES WITH OTC DRUG
K943314 · Johnson & Johnson Consumer Products, Inc. · Jan 1996
DERMIVIEW HYPOALLERGENIC CLEAR TAPE
K944587 · Johnson & Johnson Medical, Inc. · Oct 1995
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
BAND-AID(TM) BRAND ADHESIVE BANDAGE
K940536 · Johnson & Johnson Consumer Products, Inc. · Oct 1994