510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142428Substantially Equivalent

Shock Pulse-SE Lithotripsy System CYBERWAND II

Cybersonics, Inc., Erie PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142428 is the FDA 510(k) clearance record for Shock Pulse-SE Lithotripsy System CYBERWAND II, a class II device, cleared for Cybersonics, Inc. on under FDA product code FEO (Lithotriptor, Ultrasonic). FDA records list 7 510(k) clearances for Cybersonics, Inc., from to . As of , FDA records show one recall naming K142428.

Clearance record

Decision date
Received
(76 days to decision)
Product code
FEO Lithotriptor, Ultrasonic
Regulation
21 CFR 876.4480
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cybersonics, Inc. 5340 Fryling Rd., Erie PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEO

Trailing 12 months

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

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