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FDA 510(k)

SILS PORT

K-Number: K103253 · 2011-02-24

ApplicantCoviden (Formerly Registered AS US Surgical, A Div
Decision Date2011-02-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Coviden (Formerly Registered AS US Surgical, A Div. It received FDA 510(k) clearance on 2011-02-24 under 510(k) number K103253. 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 SILS PORT?

SILS PORT is a medical device that received FDA 510(k) clearance on 2011-02-24. The listed applicant is Coviden (Formerly Registered AS US Surgical, A Div. The 510(k) number is K103253.

When did SILS PORT receive FDA 510(k) clearance?

SILS PORT received FDA 510(k) clearance on 2011-02-24, under 510(k) number K103253.

Who is the listed applicant for SILS PORT?

The FDA 510(k) record lists Coviden (Formerly Registered AS US Surgical, A Div as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILS PORT?

The FDA product code for SILS PORT is GCJ.

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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