OTZ · Class I · 21 CFR 886.4300

FDA Product Code OTZ: Graft Insertion Instrument For Endothelial Keratoplasty

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.

Leading manufacturers include Ocular Systems, Inc., Kaneka Corp. and Fischer Surgical, Inc..

5
Total
5
Cleared
424d
Avg days
2011
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Graft Insertion Instrument For Endothelial Keratoplasty Devices (Product Code OTZ)

5 devices
1–5 of 5
Cleared Feb 02, 2022
EndoSerter-PL
K203586
Corneagen, Inc.
Ophthalmic · 421d
Cleared Oct 03, 2012
EK DELIVERY DEVICE
K121579
Tdak Medical, Inc.
Ophthalmic · 126d
Cleared May 31, 2012
NCI SPATULA
K110734
Fischer Surgical, Inc.
Ophthalmic · 442d
Cleared Dec 29, 2011
TRIMOTION INJECTOR
K102999
Kaneka Corp.
Ophthalmic · 447d
Cleared Jan 21, 2011
ENDOSERTER
K090626
Ocular Systems, Inc.
Ophthalmic · 683d

About Product Code OTZ - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code OTZ since 2011, with 5 receiving FDA clearance (average review time: 424 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.