# K012023: Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Sep 12, 2001 after 76 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790187 (1979). 3 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900903: Kopans Hookwire Lesion Localization Needle, Milex Products, Inc. (1990) Summary page 1.
- K790187: Bovie Hand Control, Sybron Corp. (1979) Summary page 1.
- K963813: Sure Core Biopsy Kit, Interventional Concepts, Inc. (1997) Summary page 1.
- (no number) Kopans Breast Lesion Localization Needle: named in the summary without a submission number
- (no number) PrecisionGuide Breast Lesion Localization Needle: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K881687: Cavitron Electrosurgical Module (Cem) and Pak, Cavitron Surgical Systems (1988). Our OCR of the scanned summary read K881687, FDA’s number for Cavitron Electrosurgical Module (Cem) and Pak (Cavitron Surgical Systems). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bovie Hand Control”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K022314: Sanarus Visica Treatment System (2002), 29 descendants of its own
- K052861: Modification to:Sanarus Visica Treatment System , Models VS2000 (2005), 28 descendants of its own
- K061510: Sanarus Visica Treatment System (2006), 27 descendants of its own
- K062896: V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600 (2007), 26 descendants of its own
- K102360: Icesence 3 (2010), 25 descendants of its own

## Indications for use
The Anchor Guide™ Localization Device is indicated for localization of breast lesions.

Source page: https://510kreport.com/device/K012023
Methodology: https://510kreport.com/methodology