510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033335Substantially Equivalent

Lithostar Modularis with Shockwave System Cplus

Siemens Medical Solutions USA, Inc., Mavern PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033335 is the FDA 510(k) clearance record for LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code MMZ (Table, Cystometric, Electric). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show one recall naming K033335.

Clearance record

Decision date
Received
(40 days to decision)
Product code
MMZ Table, Cystometric, Electric
Regulation
21 CFR 876.4890
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy., Mavern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMZ

Trailing 12 months

FDA records hold no clearances under product code MMZ in the trailing twelve months.

FDA records show no clearances under product code MMZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MMZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260