Cleared Traditional

K923319 - SHAWNEE PRODUCT KIT IV

K923319 is an FDA 510(k) clearance for SHAWNEE PRODUCT KIT IV, manufactured by Absentee Shawnee Bandage Group. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K923319 · Absentee Shawnee Bandage Group · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K923319

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.

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 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K923319.
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
K935725 · Deroyal Industries, Inc. · Feb 1994
3M TEGADERM HP TRANSPARENT DRESSING
K932422 · 3M Health Care, Ltd. · Dec 1993
TISSUE ISOLATION AND RETRIEVAL BAG
K931886 · Advanced Surgical, Inc. · Sep 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
K923235 · Johnson & Johnson Medical, Inc. · May 1993
ISOPORE(TM) TAPE, MODIFICATION
K925384 · Lectec Corp. · Apr 1993
STRAPPAL
K922897 · Smith & Nephew United, Inc. · Sep 1992