510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083614Substantially Equivalent

Sonolith I-Sys Lithotriper

Technomed Medical Systems, SA, Mount Dora FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083614 is the FDA 510(k) clearance record for SONOLITH I-SYS LITHOTRIPER, a class II device, cleared for Technomed Medical Systems, SA on under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological). FDA records list one 510(k) clearance for Technomed Medical Systems, SA. As of , FDA records show no recalls naming K083614.

Clearance record

Decision date
Received
(231 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
Technomed Medical Systems, SA 106 E. 5th Ave., Mount Dora FL
510(k) summary
Summary PDF
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