FDA 510(k) Applications Submitted by Edward J. Sinclair
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110696 |
03/14/2011 |
NEURO CHECK DEVICE WITH IO-FLEX WIRE |
BAXANO, INC. |
| K142619 |
09/16/2014 |
Snap Insulin Pump System |
ASANTE SOLUTIONS, INC |
| K153080 |
10/23/2015 |
RTVue XR OCT Avanti with AngioVue Software |
OPTOVUE, INC. |
| K113533 |
11/30/2011 |
NEURO CHECK DEVICE WITH IO-FLEX WIRE |
BAXANO, INC. |
| K100958 |
04/07/2010 |
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES |
BAXANO, INC. |
| K972777 |
07/25/1997 |
TEMPORARY OCCLUSION BALLOON SYSTEM |
PERCUSURGE, INC. |
| K102594 |
09/09/2010 |
IO-FLEX CATHETER |
BAXANO, INC. |
| K113073 |
10/17/2011 |
IO-TOME DEVICE |
BAXANO, INC. |
| K181662 |
06/25/2018 |
Iridex TruFocus LIO Premiere |
Iridex Corporation |
| K201953 |
07/14/2020 |
OMNI PLUS Surgical System |
Sight Sciences, Inc. |
| K202678 |
09/15/2020 |
OMNI Surgical System |
Sight Sciences, Inc. |
| K213045 |
09/22/2021 |
TearCare System |
Sight Sciences, Inc. |
| K163475 |
12/12/2016 |
iVue |
Optovue, Inc. |
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