FDA 510(k) Applications Submitted by Caldera Medical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K072456 |
08/31/2007 |
DESARA MESH SLING, MODEL CAL-DS01 |
CALDERA MEDICAL, INC. |
| K083722 |
12/15/2008 |
ASCEND |
CALDERA MEDICAL, INC. |
| K060004 |
01/03/2006 |
CALDERA MESH |
CALDERA MEDICAL, INC. |
| K053424 |
12/08/2005 |
POPMESH |
CALDERA MEDICAL, INC. |
| K150016 |
01/05/2015 |
Vertessa Lite |
CALDERA MEDICAL, INC. |
| K150023 |
01/06/2015 |
Vertessa Lite Y-Mesh |
CALDERA MEDICAL, INC. |
| K120327 |
02/02/2012 |
VERTESSA |
CALDERA MEDICAL, INC. |
| K101169 |
04/26/2010 |
DESARA MESH MODEL: CAL-DS01 |
CALDERA MEDICAL, INC. |
| K101462 |
05/26/2010 |
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH |
CALDERA MEDICAL, INC. |
| K191416 |
05/28/2019 |
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack |
Caldera Medical, Inc. |
| K211975 |
06/25/2021 |
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System |
Caldera Medical, Inc. |
| K121928 |
07/02/2012 |
DESARA SL |
CALDERA MEDICAL, INC. |
| K132069 |
07/03/2013 |
DESARA MESH, DESARA BLUE |
CALDERA MEDICAL, INC. |
| K162201 |
08/05/2016 |
Desara TV, Desara Blue TV |
CALDERA MEDICAL, INC. |
| K172614 |
08/31/2017 |
Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medic |
Caldera Medical, Inc. |
| K112609 |
09/08/2011 |
DESARA MESH |
CALDERA MEDICAL, INC. |
| K123028 |
09/28/2012 |
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH |
CALDERA MEDICAL, INC. |
| K192811 |
09/30/2019 |
BenestaTM Tissue Removal Device |
Caldera Medical, Inc. |
| K192822 |
10/01/2019 |
Benesta Hysteroscope |
Caldera Medical, Inc. |
| K103418 |
11/22/2010 |
DESARA MINI |
CALDERA MEDICAL, INC. |
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