Cleared Traditional

SHAWNEE PRODUCT KIT IV (K923319) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K923319 · Absentee Shawnee Bandage Group · General & Plastic Surgery device
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Jun 1993
Decision
345d
Days
Class 1
Risk

K923319 is an FDA 510(k) clearance for the SHAWNEE PRODUCT KIT IV. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Absentee Shawnee Bandage Group (Tecumseh, US). The FDA issued a Cleared decision on June 17, 1993 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Absentee Shawnee Bandage Group devices

Submission Details

510(k) Number K923319 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received July 07, 1992
Decision Date June 17, 1993
Days to Decision 345 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 115d · This submission: 345d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 20
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K923319.
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · Medtronic Vascular · Apr 1992
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · Quinton, Inc. · Oct 1989
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989