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ANCHOR GUIDE LESION LOCALIZATION DEVICE - Rf Generator Cable

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012023

by Senorx, Inc.

Identifiers

510(k) Number
K012023 FDA 510(k)
FDA Product Code
KNW FDA 510(k)
Models / Variants
Anchor Guide Lesion Localization Device FDA 510(k)
Ancor Guide Holder FDA 510(k)
Rf Generator Cable FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1075 FDA 510(k)
Regulation Number
876.1075 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Anchor Guide Lesion Localization Device is a single-use electrosurgical device used to localize and fixate a target lesion in the breast. It consists of the Ancor Guide Holder and RF Generator Cable components. This device is designed to assist in the precise positioning of breast lesions during medical procedures.

The device is supplied as a single-use, sterile product and is not intended for reuse. It is classified under product code KNW and received FDA 510(k) clearance with K number K012023 on September 12, 2001, as substantially equivalent. The device is intended for use in gastroenterology and urology procedures.

Frequently asked questions

What is the Anchor Guide Lesion Localization Device used for?

The Anchor Guide is a single-use electrosurgical device designed to localize and fixate target lesions in the breast, assisting in precise positioning during medical procedures in gastroenterology and urology.

Is the Anchor Guide device reusable or single-use?

The Anchor Guide Lesion Localization Device is supplied as a single-use, sterile product and is not intended for reuse to ensure patient safety and device performance.

What components make up the Anchor Guide system?

The device consists of two main components: the Ancor Guide Holder and the RF Generator Cable, which work together to facilitate lesion localization during procedures.

What regulatory clearance has the Anchor Guide device received?

The device has received FDA 510(k) clearance with K number K012023 on September 12, 2001, classified as substantially equivalent under product code KNW for gastroenterology and urology procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Anchor Guide Lesion Localization Device; Ancor Guide Holder; Rf ..., Anchor Guide Lesion Localization Device; Ancor Guide Holder; Rf ..., Anchor Guide Lesion Localization Device; Ancor Guide Holder; Rf ..., www.accessdata.fda.gov, A prospective, randomized, multicenter clinical trial to evaluate the ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Senorx, Inc.

Sources (1)

  • FDA 510(k) K012023 24 fields · synced Sep 23, 2026