Cleared Traditional

K926585 - THOROCOSCOPY SELF-RETAINING RETRACTOR

K926585 is an FDA 510(k) clearance for THOROCOSCOPY SELF-RETAINING RETRACTOR, manufactured by T. Korossurgical Instruments Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 322-day FDA review.

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

FDA 510(k) Submission Details - K926585

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
207d slower than avg
Panel avg: 115d · This submission: 322d
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 46
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K926585.
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · Medtronic, Inc. · Oct 2013
QUADRANT RETRACTOR SYSTEM
K043602 · Medtronic Sofamor Danek · Feb 2005
LUNG RETRACTORS: DAVIDSON, SEMB
K930316 · Thomasville Medical Assoc. · Feb 1994
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