Cleared Traditional

K844061 - MICROTEK IRRIGATION SYSTEM (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K844061 · Microtek Medical, Inc. · General & Plastic Surgery device
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May 1985
Decision
215d
Days
Class 1
Risk

K844061 is an FDA 510(k) clearance for the MICROTEK IRRIGATION SYSTEM. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Microtek Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 215 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Microtek Medical, Inc. devices

Submission Details

510(k) Number K844061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1984
Decision Date May 21, 1985
Days to Decision 215 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
101d slower than avg
Panel avg: 114d · This submission: 215d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.