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FDA 510(k)

MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM

K-Number: K070712 · 2007-03-28

ApplicantSurgical Innovations Group Plc
Decision Date2007-03-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Innovations Group Plc. It received FDA 510(k) clearance on 2007-03-28 under 510(k) number K070712. 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 MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM?

MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-28. The listed applicant is Surgical Innovations Group Plc. The 510(k) number is K070712.

When did MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM received FDA 510(k) clearance on 2007-03-28, under 510(k) number K070712.

Who is the listed applicant for MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM?

The FDA 510(k) record lists Surgical Innovations Group Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM?

The FDA product code for MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM 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 Surgical Innovations Group Plc 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.

K100442FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

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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