510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K042427Substantially Equivalent

Genestone Exel (Xl) Extracorporeal Shock Wave Lithotripter

Genemed, Inc., Woodbury CT / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K042427 is the FDA 510(k) clearance record for GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, a class II device, cleared for Genemed, Inc. on under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological). FDA records list 2 510(k) clearances for Genemed, Inc., from to . As of , FDA records show no recalls naming K042427.

Clearance record

Decision date
Received
(86 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
Genemed, Inc. 660 Main St. S., Woodbury CT
510(k) summary
Statement
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