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FDA 510(k)

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

K-Number: K211975 · 2021-11-10

ApplicantCaldera Medical, Inc.
Decision Date2021-11-10
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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 is a medical device manufactured by Caldera Medical, Inc.. It received FDA 510(k) clearance on 2021-11-10 under approval number K211975. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2021-11-10. It is manufactured by Caldera Medical, Inc.. The 510(k) number is K211975.

When was 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 approved by the FDA?

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 received FDA 510(k) clearance on 2021-11-10, under approval number K211975.

What company makes 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?

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 is manufactured by Caldera Medical, Inc..

What is the FDA product code 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?

The FDA product code 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 is OTN.

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Related Devices (Code: OTN)

K162201Desara TV, Desara Blue TVCaldera Medical, Inc. K183134ArcTV Transvaginal Sling SystemUrocure, LLC K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged GuideETHICON, Inc. K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation K210087Athena Surgical RMUS SystemAthena Surgical, LLC K222293ArcSP Suprapubic Sling SystemUrocure, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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