Cleared Special

K033335 - LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS

K033335 is an FDA 510(k) clearance for LITHOSTAR MODULARIS WITH SHOCKWAVE SYST..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MMZ cleared through the Special 510(k) pathway after a 40-day FDA review.

K033335 · Siemens Medical Solutions USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
40d
Days
Class 2
Risk

K033335 is an FDA 510(k) clearance for the LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS. Classified as Table, Cystometric, Electric (product code MMZ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on November 25, 2003 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4890 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033335

510(k) Number K033335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2003
Decision Date November 25, 2003
Days to Decision 40 days
Submission Type Special
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
91d faster than avg
Panel avg: 131d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

MMZ Device Classification - Class 2, Special Controls

Product Code MMZ Table, Cystometric, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4890
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.

K033335 · LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
Download PDF FDA Summary Siemens Medical Solut…