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

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Caldera Medical, Inc.

The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for 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.

Pre-market Notification Details

Device IDK211975
510k NumberK211975
Device Name: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
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant Caldera Medical, Inc. 4360 Park Terrace Drive Westlake Village,  CA  91361
ContactVicki Gail
CorrespondentVicki Gail
Caldera Medical, Inc. 4360 Park Terrace Drive Westlake Village,  CA  91361
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-25
Decision Date2021-11-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00890594000117 K211975 000
00890594000100 K211975 000
00890594000094 K211975 000
00890594000087 K211975 000

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