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Anchorage Access Kit

by Epitek, Inc. 510(k)

Active United States

510(k) K073507

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073507 Date5 Mar 2008ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ODC
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Anchorage Access Kit is an Endoscope Channel Accessory that facilitates percutaneous access to establish a guide through which surgical instruments or devices can be intubated. It is designed to gain percutaneous access and provide a conduit for surgical instruments, specifically the Anchorage Closure Device or other compatible tools.

The Anchorage Access Kit is used by clinicians in a surgical setting to facilitate the placement of instruments through a guide. It is classified as a Class 2 device and is regulated under regulation number 876.1500, with a product code of ODC. The device has been cleared by the FDA with a 510(k) number of K073507, with a decision date of 2008-03-05.

Other devices from Epitek, Inc.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Anchorage Access Kit used for?

    The Anchorage Access Kit is used by clinicians in a surgical setting to facilitate the placement of instruments through a guide, specifically for devices like the Anchorage Closure Device.

  • Is the Anchorage Access Kit a single-use or reusable device?

    The device data does not explicitly state whether the Anchorage Access Kit is single-use or reusable, but it is classified as a Class 2 device.

  • What is the regulatory classification of the Anchorage Access Kit?

    The Anchorage Access Kit is regulated under regulation number 876.1500, with a product code of ODC, and has been cleared by the FDA with a 510(k) number of K073507.

  • What type of surgical instruments can be used with the Anchorage Access Kit?

    The Anchorage Access Kit provides a conduit for surgical instruments, specifically the Anchorage Closure Device or other compatible tools.