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FDA 510(k)

ANCHORAGE CLOSURE DEVICE

K-Number: K073096 · 2008-02-07

ApplicantEpitek, Inc.
Decision Date2008-02-07
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANCHORAGE CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Epitek, Inc.. It received FDA 510(k) clearance on 2008-02-07 under 510(k) number K073096. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANCHORAGE CLOSURE DEVICE?

ANCHORAGE CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2008-02-07. The listed applicant is Epitek, Inc.. The 510(k) number is K073096.

When did ANCHORAGE CLOSURE DEVICE receive FDA 510(k) clearance?

ANCHORAGE CLOSURE DEVICE received FDA 510(k) clearance on 2008-02-07, under 510(k) number K073096.

Who is the listed applicant for ANCHORAGE CLOSURE DEVICE?

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 CLOSURE DEVICE?

The FDA product code for ANCHORAGE CLOSURE DEVICE is GAT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 000003K073507ANCHORAGE ACCESS KIT

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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