Cleared Traditional

K001240 - SERAGARD INJECTION PATCH

K001240 is an FDA 510(k) clearance for SERAGARD INJECTION PATCH, manufactured by Platinum Services, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K001240 · Platinum Services, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
64d
Days
Class 1
Risk

K001240 is an FDA 510(k) clearance for the SERAGARD INJECTION PATCH. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Platinum Services, Inc. (Dequincy, US). The FDA issued a Cleared decision on June 21, 2000 after a review of 64 days - a notably fast clearance cycle.

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: 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 Platinum Services, Inc. devices

FDA 510(k) Submission Details - K001240

510(k) Number K001240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2000
Decision Date June 21, 2000
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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 90
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K001240.
CARE BAND ANTIBACTERIAL BANDAGES
K983368 · Aso Corp. · Feb 1999
SYVEK PATCH
K972914 · Marine Polymer Technologies, Inc. · Dec 1997
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
EMPI TAPE PATCHES
K941389 · Empi · Aug 1994