Cleared Traditional

K864384 - LUXTEC RETRACTORS

K864384 is an FDA 510(k) clearance for LUXTEC RETRACTORS, manufactured by Luxtec Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K864384 · Luxtec Corp. · General & Plastic Surgery device
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Nov 1986
Decision
14d
Days
Class 1
Risk

K864384 is an FDA 510(k) clearance for the LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Luxtec Corp. (Sturbridge, US). The FDA issued a Cleared decision on November 19, 1986 after a review of 14 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 Luxtec Corp. devices

FDA 510(k) Submission Details - K864384

510(k) Number K864384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date November 19, 1986
Days to Decision 14 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 faster than avg
Panel avg: 115d · This submission: 14d
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 47
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K864384.
SUCTION RETRACTOR
K875289 · T. Korossurgical Instruments Corp. · Jan 1988
ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000
K874243 · Pilling Co. · Nov 1987
STERI-TRACTOR WOUND RETRACTOR
K870543 · 3M Company · Feb 1987
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985
WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS
K852530 · The Huxley Instrument Corp. · Jun 1985
21-450 GELPI RETRACTOR
K851776 · Artiberia · Jun 1985