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FDA 510(k)

OMNIPORT

K-Number: K002013 · 2000-09-29

ApplicantAdvanced Surgical Concepts (Asc)
Decision Date2000-09-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNIPORT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Concepts (Asc). It received FDA 510(k) clearance on 2000-09-29 under 510(k) number K002013. 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 OMNIPORT?

OMNIPORT is a medical device that received FDA 510(k) clearance on 2000-09-29. The listed applicant is Advanced Surgical Concepts (Asc). The 510(k) number is K002013.

When did OMNIPORT receive FDA 510(k) clearance?

OMNIPORT received FDA 510(k) clearance on 2000-09-29, under 510(k) number K002013.

Who is the listed applicant for OMNIPORT?

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

What is the FDA product code for OMNIPORT?

The FDA product code for OMNIPORT is GCJ.

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Other records listing Advanced Surgical Concepts (Asc) 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.

K011183OMNIPORT HAND AND INSTRUMENT ACCESS DEVICEK010711ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTORK993544SPACE-OR RETRACTOR

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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