510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920410Substantially Equivalent

Emilith Electromechanicalimpactor Lithotripsy Prob

Psi Medical Products, Inc., Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920410 is the FDA 510(k) clearance record for EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB, a class II device, cleared for Psi Medical Products, Inc. on under FDA product code FFK (Lithotriptor, Electro-Hydraulic). FDA records list 7 510(k) clearances for Psi Medical Products, Inc., from to . As of , FDA records show no recalls naming K920410.

Clearance record

Decision date
Received
(745 days to decision)
Product code
FFK Lithotriptor, Electro-Hydraulic
Regulation
21 CFR 876.4480
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Psi Medical Products, Inc. 240 Long Hill Cross Rd., Shelton CT
510(k) summary
Statement
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