510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K010340Substantially Equivalent

Modulith Lithotripsy, Model Slk for the Fragmentation of Urinary and Upper Ureteral Calculi

Karl Storz Lithotripsy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010340 is the FDA 510(k) clearance record for MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI, a class II device, cleared for Karl Storz Lithotripsy-America, Inc. on under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological). FDA records list one 510(k) clearance for Karl Storz Lithotripsy-America, Inc. As of , FDA records show no recalls naming K010340.

Clearance record

Decision date
Received
(8 days to decision)
Product code
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation
21 CFR 876.5990
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Karl Storz Lithotripsy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code LNS

Trailing 12 months
2 clearances under product code LNS in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LNS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260