Vertessa Lite

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

CALDERA MEDICAL, INC.

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

Pre-market Notification Details

Device IDK150016
510k NumberK150016
Device Name:Vertessa Lite
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Applicant CALDERA MEDICAL, INC. 5171 CLARETON DRIVE Agoura Hills,  CA  91301
ContactVicki Gail
CorrespondentVicki Gail
CALDERA MEDICAL, INC. 5171 CLARETON DRIVE Agoura Hills,  CA  91301
Product CodeOTO  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-05
Decision Date2015-04-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00890594000384 K150016 000
00890594000360 K150016 000
00890594000643 K150016 000

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