510(k) K090626
K090626 is an FDA 510(k) premarket notification submitted by Ocular Systems, Inc. for the device "ENDOSERTER". The FDA issued a decision of Substantially Equivalent on January 21, 2011. The device falls under product code OTZ (Graft Insertion Instrument For Endothelial Keratoplasty), a Class I device regulated under 21 CFR 886.4300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2011
- Date Received
- March 9, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Graft Insertion Instrument For Endothelial Keratoplasty
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type
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.