Cleared Traditional

K030346 - TWINHEADS TH-101 EXTRACORPOREAL SHOCK W...

K030346 is an FDA 510(k) clearance for TWINHEADS TH-101 EXTRACORPOREAL SHOCK W..., manufactured by Fmd, LLC. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K030346 · Fmd, LLC · Gastroenterology & Urology device
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May 2003
Decision
88d
Days
Class 2
Risk

K030346 is an FDA 510(k) clearance for the TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Fmd, LLC (Redmond, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 88 days - a notably fast clearance 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: 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 Fmd, LLC devices

FDA 510(k) Submission Details - K030346

510(k) Number K030346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2003
Decision Date May 02, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
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 18
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