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FDA 510(k)

Port Access System

K-Number: K210495 · 2021-06-18

Decision Date2021-06-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Port Access System is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Innovations Limited. It received FDA 510(k) clearance on 2021-06-18 under 510(k) 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. The listed applicant is Surgical Innovations Limited. The 510(k) number is K210495.

When did Port Access System receive FDA 510(k) clearance?

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

Who is the listed applicant for Port Access System?

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

What is the FDA product code for Port Access System?

The FDA product code for Port Access System is GCJ.

Other records listing Surgical Innovations Limited as applicant

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.

Related Devices (Code: GCJ)

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.

Official Source

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