Cleared Traditional

K895757 - IRRI-EVACUATOR

K895757 is an FDA 510(k) clearance for IRRI-EVACUATOR, manufactured by Mikro-Tek Laboratories. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K895757 · Mikro-Tek Laboratories · General & Plastic Surgery device
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Oct 1989
Decision
23d
Days
Class 1
Risk

K895757 is an FDA 510(k) clearance for the IRRI-EVACUATOR. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Mikro-Tek Laboratories (Bloomington, US). The FDA issued a Cleared decision on October 19, 1989 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mikro-Tek Laboratories devices

FDA 510(k) Submission Details - K895757

510(k) Number K895757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date October 19, 1989
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

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.

Regulatory Peers - GBX Catheter, Irrigation

All 50
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K895757.
PVC ROUND WOUND DRAINS
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THORACIC CATHETERS
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CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704 · American Pharmaseal Div. Ahsc · Mar 1987
MICROTEK IRRIGATION SYSTEM
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