510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123038Substantially Equivalent

Swiss Lithobreaker

E.M.S. - Electro Medical Systems SA, Southbrough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123038 is the FDA 510(k) clearance record for SWISS LITHOBREAKER, a class II device, cleared for E.M.S Electro Medical Systems S.A on under FDA product code FFK (Lithotriptor, Electro-Hydraulic). FDA records list 41 510(k) clearances for E.M.S Electro Medical Systems S.A, from to . As of , FDA records show no recalls naming K123038.

Clearance record

Decision date
Received
(110 days to decision)
Product code
FFK Lithotriptor, Electro-Hydraulic
Regulation
21 CFR 876.4480
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
E.M.S Electro Medical Systems S.A 225 Tpke. Rd., Southbrough MA
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