ENDOSERTER
Graft Insertion Instrument For Endothelial Keratoplasty
OCULAR SYSTEMS, INC.
The following data is part of a premarket notification filed by Ocular Systems, Inc. with the FDA for Endoserter.
Pre-market Notification Details
| Device ID | K090626 |
| 510k Number | K090626 |
| Device Name: | ENDOSERTER |
| Classification | Graft Insertion Instrument For Endothelial Keratoplasty |
| Applicant | OCULAR SYSTEMS, INC. 101 N CHESTNUT STREET SUITE 301 Winston-salem, NC 27101 |
| Contact | Kurt Weber |
| Correspondent | Kurt Weber OCULAR SYSTEMS, INC. 101 N CHESTNUT STREET SUITE 301 Winston-salem, NC 27101 |
| Product Code | OTZ |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-09 |
| Decision Date | 2011-01-21 |
Trademark Results [ENDOSERTER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSERTER 85071577 3956038 Live/Registered |
OCULAR SYSTEMS, LLC 2010-06-25 |
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