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FDA 510(k)

SILS PORT, MODELS SILSPT5, SILSPT12

K-Number: K082619 · 2008-11-07

ApplicantCovidien Lp, Formerly Registered AS United States
Decision Date2008-11-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILS PORT, MODELS SILSPT5, SILSPT12 is the device name listed in this FDA 510(k) record. The listed applicant is Covidien Lp, Formerly Registered AS United States. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K082619. 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, MODELS SILSPT5, SILSPT12?

SILS PORT, MODELS SILSPT5, SILSPT12 is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Covidien Lp, Formerly Registered AS United States. The 510(k) number is K082619.

When did SILS PORT, MODELS SILSPT5, SILSPT12 receive FDA 510(k) clearance?

SILS PORT, MODELS SILSPT5, SILSPT12 received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082619.

Who is the listed applicant for SILS PORT, MODELS SILSPT5, SILSPT12?

The FDA 510(k) record lists Covidien Lp, Formerly Registered AS United States as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILS PORT, MODELS SILSPT5, SILSPT12?

The FDA product code for SILS PORT, MODELS SILSPT5, SILSPT12 is GCJ.

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Other records listing Covidien Lp, Formerly Registered AS United States 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.

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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

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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