Cleared Traditional

K092033 - VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR

K092033 is an FDA 510(k) clearance for VIBROLITH AND VIBROLITH PLUS INTRACORPO..., manufactured by Elmed USA. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K092033 · Elmed USA · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2010
Decision
298d
Days
Class 2
Risk

K092033 is an FDA 510(k) clearance for the VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Elmed USA (Appollo Beach, US). The FDA issued a Cleared decision on April 30, 2010 after a review of 298 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - 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 Elmed USA devices

FDA 510(k) Submission Details - K092033

510(k) Number K092033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date April 30, 2010
Days to Decision 298 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
167d slower than avg
Panel avg: 131d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFK Device Classification - Class 2, Special Controls

Product Code FFK Lithotriptor, Electro-hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
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 - FFK Lithotriptor, Electro-hydraulic

All 45
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K092033.
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
K120303 · Cybersonics, Inc. · Jun 2012
URETRON MODEL URT
K111058 · Med-Sonics Corp. · Mar 2012
CYBERWAND LITHOTRIPTER
K102169 · Cybersonics, Inc. · Aug 2010
CYBERWAND STERILE PADS, MODEL: CW-RBPBX
K072422 · Cybersonics, Inc. · Oct 2007
LMA STONEBREAKER DEVICE
K062475 · The Laryngeal Mask Co., Ltd. · May 2007
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
K052135 · Cybersonics, Inc. · Dec 2005