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FDA 510(k)

SILS PORT MODEL SILSPT15

K-Number: K093372 · 2009-12-03

ApplicantCovidien Lp, Formerly Registered AS Tyco Healthcar
Decision Date2009-12-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILS PORT MODEL SILSPT15 is the device name listed in this FDA 510(k) record. The listed applicant is Covidien Lp, Formerly Registered AS Tyco Healthcar. It received FDA 510(k) clearance on 2009-12-03 under 510(k) number K093372. 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 MODEL SILSPT15?

SILS PORT MODEL SILSPT15 is a medical device that received FDA 510(k) clearance on 2009-12-03. The listed applicant is Covidien Lp, Formerly Registered AS Tyco Healthcar. The 510(k) number is K093372.

When did SILS PORT MODEL SILSPT15 receive FDA 510(k) clearance?

SILS PORT MODEL SILSPT15 received FDA 510(k) clearance on 2009-12-03, under 510(k) number K093372.

Who is the listed applicant for SILS PORT MODEL SILSPT15?

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

What is the FDA product code for SILS PORT MODEL SILSPT15?

The FDA product code for SILS PORT MODEL SILSPT15 is GCJ.

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Related Devices (Code: GCJ)

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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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