Cleared Traditional

K111947 - DUET MAGNA

K111947 is an FDA 510(k) clearance for DUET MAGNA, manufactured by Direx Systems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K111947 · Direx Systems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Mar 2012
Decision
237d
Days
Class 2
Risk

K111947 is an FDA 510(k) clearance for the DUET MAGNA. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Direx Systems Corp. (Canton, US). The FDA issued a Cleared decision on March 1, 2012 after a review of 237 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - the FDA gastroenterology and urology 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Direx Systems Corp. devices

FDA 510(k) Submission Details - K111947

510(k) Number K111947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2011
Decision Date March 01, 2012
Days to Decision 237 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 131d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNS Device Classification - Class 2, Special Controls

Product Code LNS Lithotriptor, Extracorporeal Shock-wave, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5990
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

All 41
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K111947.
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K130729 · Dornier Medtech Systems · May 2013
GEMINI LITHOTRIPTER
K121656 · Dornier Medtech America, Inc. · Sep 2012
MODULTH SLK
K120769 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
LITE-MED LM-9200 ELMA
K103217 · Lite-Med, Inc. · Sep 2011
SONOLITH I-MOVE
K111808 · Edap Tms France · Aug 2011
EM-9000
K101482 · Elite Medical, Inc. · Mar 2011