510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K092033Substantially Equivalent

Vibrolith and Vibrolith Plus Intracorporeal Lithotriptor

Elmed USA, Appollo Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092033 is the FDA 510(k) clearance record for VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR, a class II device, cleared for Elmed USA on under FDA product code FFK (Lithotriptor, Electro-Hydraulic). FDA records list one 510(k) clearance for Elmed USA. As of , FDA records show no recalls naming K092033.

Clearance record

Decision date
Received
(298 days to decision)
Product code
FFK Lithotriptor, Electro-Hydraulic
Regulation
21 CFR 876.4480
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Elmed USA 962 Allegro Ln., Appollo Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FFK

Trailing 12 months

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

FDA records show no clearances under product code FFK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFK, 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