Cleared Traditional

K843206 - COOK COUNTY HOSPITAL DRESSING CHANGE SET

K843206 is an FDA 510(k) clearance for COOK COUNTY HOSPITAL DRESSING CHANGE SET, manufactured by Geneva Laboratories, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K843206 · Geneva Laboratories, Inc. · General & Plastic Surgery device
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May 1985
Decision
282d
Days
Class 1
Risk

K843206 is an FDA 510(k) clearance for the COOK COUNTY HOSPITAL DRESSING CHANGE SET. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Geneva Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on May 24, 1985 after a review of 282 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Geneva Laboratories, Inc. devices

FDA 510(k) Submission Details - K843206

510(k) Number K843206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1984
Decision Date May 24, 1985
Days to Decision 282 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
167d slower than avg
Panel avg: 115d · This submission: 282d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDD Kit, Surgical Instrument, Disposable

All 31
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K843206.
INCISION AND DRAINAGE KIT
K910369 · Megadyne Medical Products, Inc. · Mar 1991
ENTERON ABDOMINAL PARACENTESIS TRAY
K874063 · Endovations · Dec 1987
SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW
K871458 · Fraass Survival Systems, Inc. · Jul 1987
C-SECTION TRAY
K842627 · Deroyal Industries, Inc. · Sep 1984
STERILE SOLUTION BOWL
K843115 · E.M. Adams · Sep 1984
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984