Cleared Traditional

K890917 - PHOENIX DRAPES WITH MICROBAN

K890917 is an FDA 510(k) clearance for PHOENIX DRAPES WITH MICROBAN, manufactured by Phoenix Medical Technology, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K890917 · Phoenix Medical Technology, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
175d
Days
Class 1
Risk

K890917 is an FDA 510(k) clearance for the PHOENIX DRAPES WITH MICROBAN. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Phoenix Medical Technology, Inc. (Fort Worth, US). The FDA issued a Cleared decision on August 17, 1989 after a review of 175 days - an extended review 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: 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.

View all Phoenix Medical Technology, Inc. devices

FDA 510(k) Submission Details - K890917

510(k) Number K890917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1989
Decision Date August 17, 1989
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
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 K890917.
OPSITE I.V. 3000
K895353 · Smith & Nephew United, Inc. · Sep 1989
COMFEEL TRANSPARENT DRESSING
K894916 · Coloplast A/S · Sep 1989
ACTIDERM (TM) DERMATOLOGICAL PATCH
K895376 · Convatec, A Division of E.R. Squibb & Sons · Sep 1989
PRIMAPORE I.V.
K893900 · Smith & Nephew United, Inc. · Aug 1989
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
MACROPORE MEDICAL/SURGICAL PAPER TAPE
K884108 · Lectec Corp. · Nov 1988