Cleared Traditional

K870543 - STERI-TRACTOR WOUND RETRACTOR

K870543 is the FDA 510(k) clearance for STERI-TRACTOR WOUND RETRACTOR by 3M Company. It is a Class 1 General & Plastic Surgery device (product code GAD) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K870543 · 3M Company · General & Plastic Surgery device
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Feb 1987
Decision
15d
Days
Class 1
Risk

K870543 is an FDA 510(k) clearance for the STERI-TRACTOR WOUND RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on February 24, 1987 after a review of 15 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 3M Company devices

Submission Details

510(k) Number K870543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1987
Decision Date February 24, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
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 34
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K870543.
SURGICAL RETRACTORS
K890248 · Kinetic Medical Products · Jan 1989
SURGICAL WIRE CUTTERS
K890250 · Kinetic Medical Products · Jan 1989
ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000
K874243 · Pilling Co. · Nov 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