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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI

Manufacturer

KARL STORZ LITHOTRIPSY-AMERICA, INC.

Date Cleared

2001-02-13

(8 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K023535,K053640,K072538

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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