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FDA 510(k)

Transvaginal Access Platform

K-Number: K191294 · 2019-09-06

ApplicantApplied Medical Resources Corp.
Decision Date2019-09-06
Product CodeHEW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Transvaginal Access Platform is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191294. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transvaginal Access Platform?

Transvaginal Access Platform is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K191294.

When did Transvaginal Access Platform receive FDA 510(k) clearance?

Transvaginal Access Platform received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191294.

Who is the listed applicant for Transvaginal Access Platform?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transvaginal Access Platform?

The FDA product code for Transvaginal Access Platform is HEW.

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Related Devices (Code: HEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceApplied Medical Resources Corp.K201086Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.K180429Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.K161065ColpoWave™ Colpotomizer and CerviGrip™ Uterine ManipulatorSurgitools Pty , Ltd.

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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