Cleared Traditional

COOK COUNTY HOSPITAL DRESSING CHANGE SET (K843206) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K843206 · Geneva Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.