Cleared Traditional

K132645 - THORATRAK MICS RETRACTOR SYSTEM

K132645 is the FDA 510(k) clearance for THORATRAK MICS RETRACTOR SYSTEM by Medtronic, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAD) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K132645 · Medtronic, Inc. · General & Plastic Surgery device
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Oct 2013
Decision
42d
Days
Class 1
Risk

K132645 is an FDA 510(k) clearance for the THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 4, 2013 after a review of 42 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 Medtronic, Inc. devices

Submission Details

510(k) Number K132645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2013
Decision Date October 04, 2013
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 17
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K132645.
QUADRANT RETRACTOR SYSTEM
K043602 · Medtronic Sofamor Danek · Feb 2005
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992
ROLLET RETRACTOR
K891892 · Zinnanti Surgical Instruments, Inc. · Apr 1989
KIRSCHNER RETRACTOR
K891031 · Zinnanti Surgical Instruments, Inc. · Apr 1989
STERI-TRACTOR WOUND RETRACTOR
K870543 · 3M Company · Feb 1987
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985