510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023535Substantially Equivalent

Tripter X-1 Compact Duet

Direx Systems Corp., Natick MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023535 is the FDA 510(k) clearance record for TRIPTER X-1 COMPACT DUET, a class II device, cleared for Direx Systems Corp. on under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological). FDA records list 22 510(k) clearances for Direx Systems Corp., from to . As of , FDA records show no recalls naming K023535.

Clearance record

Decision date
Received
(88 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
Direx Systems Corp. 11 Mercer Rd., Natick MA
510(k) summary
Summary PDF
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