Cleared Traditional

K921020 - HARGIS SELF RETRACTION SYSTEM

K921020 is an FDA 510(k) clearance for HARGIS SELF RETRACTION SYSTEM, manufactured by Medin Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K921020 · Medin Corp. · General & Plastic Surgery device
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Jul 1993
Decision
486d
Days
Class 1
Risk

K921020 is an FDA 510(k) clearance for the HARGIS SELF RETRACTION SYSTEM. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Medin Corp. (Wallington, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 486 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Medin Corp. devices

FDA 510(k) Submission Details - K921020

510(k) Number K921020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1992
Decision Date July 02, 1993
Days to Decision 486 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
371d slower than avg
Panel avg: 115d · This submission: 486d
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 62
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K921020.
SCION SAPHENOUS VEIN HARVESTING SYSTEM
K963006 · Scion International, Inc. · Sep 1996
LUNG RETRACTORS: DAVIDSON, SEMB
K930316 · Thomasville Medical Assoc. · Feb 1994
THOROCOSCOPY SELF-RETAINING RETRACTOR
K926585 · T. Korossurgical Instruments Corp. · Aug 1993
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992
SUREBREATH DOME, E-Z BREATHER
K915158 · Ipax, Inc. · Feb 1992
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
K903969 · Karlin Technology, Inc. · Sep 1990