510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K102999Substantially Equivalent

Trimotion Injector

KANEKA Corporation, Settsu, Osaka, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102999 is the FDA 510(k) clearance record for TRIMOTION INJECTOR, a class I device, cleared for Kaneka Corp. on under FDA product code OTZ (Graft Insertion Instrument For Endothelial Keratoplasty). FDA's definition for product code OTZ reads: "A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed". FDA records list 11 510(k) clearances for Kaneka Corp., from to . As of , FDA records show no recalls naming K102999.

Clearance record

Decision date
Received
(447 days to decision)
Product code
OTZ Graft Insertion Instrument For Endothelial Keratoplasty
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Kaneka Corp. 5-1-1, Torikai-Nishi, Settsu, Osaka, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTZ

Trailing 12 months

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

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