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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 the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 2020-04-29 under 510(k) 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. The listed applicant is Applied Medical. The 510(k) number is K191866.

When did GelPOINT Mini Advanced Access Platform receive FDA 510(k) clearance?

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

Who is the listed applicant for GelPOINT Mini Advanced Access Platform?

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

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

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

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Other records listing Applied Medical as applicant

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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.

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Official Source

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

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