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FDA 510(k)

YelloPort Elite Port Access System

K-Number: K190592 · 2019-04-29

ApplicantSurgical Innovations Limited
Decision Date2019-04-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

YelloPort Elite Port Access System is a medical device manufactured by Surgical Innovations Limited. It received FDA 510(k) clearance on 2019-04-29 under approval number K190592. 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 YelloPort Elite Port Access System?

YelloPort Elite Port Access System is a medical device that received FDA 510(k) clearance on 2019-04-29. It is manufactured by Surgical Innovations Limited. The 510(k) number is K190592.

When was YelloPort Elite Port Access System approved by the FDA?

YelloPort Elite Port Access System received FDA 510(k) clearance on 2019-04-29, under approval number K190592.

What company makes YelloPort Elite Port Access System?

YelloPort Elite Port Access System is manufactured by Surgical Innovations Limited.

What is the FDA product code for YelloPort Elite Port Access System?

The FDA product code for YelloPort Elite Port Access System is GCJ.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Surgical Innovations Limited

K210495Port Access System

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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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