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FDA 510(k)

INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT

K-Number: K093783 · 2010-08-23

ApplicantInnovia, LLC
Decision Date2010-08-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Innovia, LLC. It received FDA 510(k) clearance on 2010-08-23 under 510(k) number K093783. 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 INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT?

INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT is a medical device that received FDA 510(k) clearance on 2010-08-23. The listed applicant is Innovia, LLC. The 510(k) number is K093783.

When did INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT receive FDA 510(k) clearance?

INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT received FDA 510(k) clearance on 2010-08-23, under 510(k) number K093783.

Who is the listed applicant for INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT?

The FDA 510(k) record lists Innovia, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT?

The FDA product code for INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT is GCJ.

Related Clinical Trials

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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Other records listing Innovia, LLC 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.

K090677INNOPORT LAPAROSCOPIC ACCESS DEVICEK060151ORBITAL TISSUE EXPANDER (OTE)

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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