Product code OTZ— Ophthalmic

EK DELIVERY DEVICE

Classification name: Graft Insertion Instrument For Endothelial Keratoplasty
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Total cleared: 5
First cleared: 2011-01-21
Most recent: 2022-02-02

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code OTZ under 21 CFR 886.4300, via openFDA

Market context for product code OTZ

FDA has cleared 5 devices under product code OTZ between 2011 and 2022, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

20221 clearance
20122 clearances
20112 clearances

Top applicants under product code OTZ

Tdak Medical, Inc.1 clearance
Ocular Systems, Inc.1 clearance
Kaneka Corp.1 clearance
Fischer Surgical, Inc.1 clearance
Corneagen, Inc.1 clearance

Recent clearances under product code OTZ

K203586 — EndoSerter-PLCorneagen, Inc.·2022-02-02
K121579 — EK DELIVERY DEVICETdak Medical, Inc.·2012-10-03
K110734 — NCI SPATULAFischer Surgical, Inc.·2012-05-31
K102999 — TRIMOTION INJECTORKaneka Corp.·2011-12-29
K090626 — ENDOSERTEROcular Systems, Inc.·2011-01-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.