Cleared Traditional

K926585 - THOROCOSCOPY SELF-RETAINING RETRACTOR (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K926585 · T. Korossurgical Instruments Corp. · General & Plastic Surgery device
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Aug 1993
Decision
322d
Days
Class 1
Risk

K926585 is an FDA 510(k) clearance for the THOROCOSCOPY SELF-RETAINING RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on August 6, 1993 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all T. Korossurgical Instruments Corp. devices

Submission Details

510(k) Number K926585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1992
Decision Date August 06, 1993
Days to Decision 322 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 114d · This submission: 322d
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.