Cleared Traditional

K882112 - MURSE RETRACTOR

K882112 is an FDA 510(k) clearance for MURSE RETRACTOR, manufactured by Euro-American Marketing Group, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K882112 · Euro-American Marketing Group, Inc. · General & Plastic Surgery device
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Jun 1988
Decision
27d
Days
Class 1
Risk

K882112 is an FDA 510(k) clearance for the MURSE RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Euro-American Marketing Group, Inc. (Mount Prospect, US). The FDA issued a Cleared decision on June 15, 1988 after a review of 27 days - a notably fast clearance 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: 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 Euro-American Marketing Group, Inc. devices

FDA 510(k) Submission Details - K882112

510(k) Number K882112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1988
Decision Date June 15, 1988
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

Product Code GAD Retractor
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 - GAD Retractor

All 61
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K882112.
SUREBREATH DOME
K884076 · Ipax, Inc. · Oct 1988
SUCTION RETRACTORS
K882074 · Karlin Technology, Inc. · Jun 1988
SELF-RETAINING SOFT TISSUE RETRACTOR
K882075 · Karlin Technology, Inc. · Jun 1988
STERNUM SPREADER AND MITRAL VALVE RETRACTOR
K881157 · T. Korossurgical Instruments Corp. · Apr 1988
UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR
K881156 · T. Korossurgical Instruments Corp. · Apr 1988
I.M.A. RETRACTOR
K881159 · T. Korossurgical Instruments Corp. · Apr 1988