Cleared Traditional

K791665 - SCOTTS SURGICAL RETRACTOR AND ELASTIC

K791665 is the FDA 510(k) clearance for SCOTTS SURGICAL RETRACTOR AND ELASTIC by Lone Star Medical Products, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAD) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K791665 · Lone Star Medical Products, Inc. · General & Plastic Surgery device
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Sep 1979
Decision
29d
Days
Class 1
Risk

K791665 is an FDA 510(k) clearance for the SCOTTS SURGICAL RETRACTOR AND ELASTIC. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Lone Star Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 19, 1979 after a review of 29 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 Lone Star Medical Products, Inc. devices

Submission Details

510(k) Number K791665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date September 19, 1979
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 39
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K791665.
EFFRON PAROTID RETRACTOR
K801759 · American V. Mueller · Aug 1980
DEEP BALFOUR BLADE FOR WILKINSON RETRACT
K801611 · Edward Weck, Inc. · Aug 1980
SPREADER
K781445 · Orthopedic Equipment Co., Inc. · Sep 1979
TISSURE RETRACTORS
K791122 · Xomed, Inc. · Jul 1979
ULTRASOUND IMAGING SYSTEM
K780993 · Boehringer Mannheim Corp. · Aug 1978
NEIVS TRACHEOTOMY RETRACTOR
K772378 · Edward Weck, Inc. · Mar 1978