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
OTZClass I

Graft Insertion Instrument For Endothelial Keratoplasty

21 CFR 886.4300 / Ophthalmic
FDA source (opens on fda.gov)

OTZ is the FDA product code for Graft Insertion Instrument For Endothelial Keratoplasty, a class I device type, regulated under 21 CFR 886.4300. FDA's definition for this code 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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OTZ
Device name
Graft Insertion Instrument For Endothelial Keratoplasty
FDA definition
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.
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code OTZ

By decision year
5 clearances under product code OTZ with a decision year between 2011 and 2022, 2011 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OTZ by decision year
YearClearances
20112
20122
20221

Applicants with the most clearances

Product code OTZ
Applicants holding the most 510(k) clearances under product code OTZ
ApplicantClearances
CorneaGen1
Fischer Surgical Inc.1
KANEKA Corporation1
Ocular Systems, Inc.1
Tdak Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code