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FDA 510(k)

ANCHORAGE ACCESS KIT

K-Number: K073507 · 2008-03-05

ApplicantEpitek, Inc.
Decision Date2008-03-05
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANCHORAGE ACCESS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Epitek, Inc.. It received FDA 510(k) clearance on 2008-03-05 under 510(k) number K073507. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANCHORAGE ACCESS KIT?

ANCHORAGE ACCESS KIT is a medical device that received FDA 510(k) clearance on 2008-03-05. The listed applicant is Epitek, Inc.. The 510(k) number is K073507.

When did ANCHORAGE ACCESS KIT receive FDA 510(k) clearance?

ANCHORAGE ACCESS KIT received FDA 510(k) clearance on 2008-03-05, under 510(k) number K073507.

Who is the listed applicant for ANCHORAGE ACCESS KIT?

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

What is the FDA product code for ANCHORAGE ACCESS KIT?

The FDA product code for ANCHORAGE ACCESS KIT is ODC.

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 Epitek, Inc. 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.

K080780ANCHORAGE SCOPE, MODEL 000003K073096ANCHORAGE CLOSURE DEVICE

Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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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