FDA 510(k)

OCTO

K-Number: K100045 · 2010-06-25

Decision Date2010-06-25

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OCTO is the device name listed in this FDA 510(k) record. The listed applicant is Dalim Surgnet Corporation. It received FDA 510(k) clearance on 2010-06-25 under 510(k) number K100045. 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 OCTO?

OCTO is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Dalim Surgnet Corporation. The 510(k) number is K100045.

When did OCTO receive FDA 510(k) clearance?

OCTO received FDA 510(k) clearance on 2010-06-25, under 510(k) number K100045.

Who is the listed applicant for OCTO?

The FDA 510(k) record lists Dalim Surgnet Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCTO?

The FDA product code for OCTO is GCJ.

Other records listing Dalim Surgnet Corporation 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.

K112196OCTOTMPORT

Related Devices (Code: GCJ)

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED 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.