510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253468Substantially Equivalent

Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)

Nova Eye Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253468 is the FDA 510(k) clearance record for Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A), a class II device, cleared for Nova Eye, Inc. on under FDA product code MPA (Endoilluminator). FDA records list one 510(k) clearance for Nova Eye, Inc. As of , FDA records show no recalls naming K253468.

Clearance record

Decision date
Received
(305 days to decision)
Product code
MPA Endoilluminator
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nova Eye, Inc. 41316 Christy St., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MPA

Trailing 12 months
1 clearance under product code MPA in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MPA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260