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FDA 510(k)

GelPOINT Mini Advanced Access Platform

K-Number: K191866 · 2020-04-29

ApplicantApplied Medical
Decision Date2020-04-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GelPOINT Mini Advanced Access Platform is a medical device manufactured by Applied Medical. It received FDA 510(k) clearance on 2020-04-29 under approval number K191866. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GelPOINT Mini Advanced Access Platform?

GelPOINT Mini Advanced Access Platform is a medical device that received FDA 510(k) clearance on 2020-04-29. It is manufactured by Applied Medical. The 510(k) number is K191866.

When was GelPOINT Mini Advanced Access Platform approved by the FDA?

GelPOINT Mini Advanced Access Platform received FDA 510(k) clearance on 2020-04-29, under approval number K191866.

What company makes GelPOINT Mini Advanced Access Platform?

GelPOINT Mini Advanced Access Platform is manufactured by Applied Medical.

What is the FDA product code for GelPOINT Mini Advanced Access Platform?

The FDA product code for GelPOINT Mini Advanced Access Platform is GCJ.

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) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (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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