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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 a medical device manufactured by Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2019-09-06 under approval 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. It is manufactured by Applied Medical Resources Corp.. The 510(k) number is K191294.

When was Transvaginal Access Platform approved by the FDA?

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

What company makes Transvaginal Access Platform?

Transvaginal Access Platform is manufactured by Applied Medical Resources Corp..

What is the FDA product code for Transvaginal Access Platform?

The FDA product code for Transvaginal Access Platform is HEW.

Related Clinical Trials

NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING NCT07578454 VRehab-SMA Phase 1.2 NOT_YET_RECRUITING NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT02603640 " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy COMPLETED NCT06647576 Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs COMPLETED NCT07573098 Digital Tool for Improved Self-management of COPD RECRUITING

Related PubMed Literature

PMID: 41790854 A Substance Use Disorder Virtual Treatment and Research Platform: A Proof of Concept. IEEE pulse (2025)

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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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