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FDA 510(k)

Port Access System

K-Number: K210495 · 2021-06-18

ApplicantSurgical Innovations Limited
Decision Date2021-06-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Port Access System is a medical device manufactured by Surgical Innovations Limited. It received FDA 510(k) clearance on 2021-06-18 under approval number K210495. 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 Port Access System?

Port Access System is a medical device that received FDA 510(k) clearance on 2021-06-18. It is manufactured by Surgical Innovations Limited. The 510(k) number is K210495.

When was Port Access System approved by the FDA?

Port Access System received FDA 510(k) clearance on 2021-06-18, under approval number K210495.

What company makes Port Access System?

Port Access System is manufactured by Surgical Innovations Limited.

What is the FDA product code for Port Access System?

The FDA product code for Port Access System is GCJ.

Related Clinical Trials

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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

K190592YelloPort Elite Port Access System

Related Devices (Code: GCJ)

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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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