Cleared Traditional

K012023 - ANCHOR GUIDE LESION LOCALIZATION DEVICE

Also marketed or referenced as:
ANCOR GUIDE HOLDER RF GENERATOR CABLE

K012023 is an FDA 510(k) clearance for ANCHOR GUIDE LESION LOCALIZATION DEVICE, manufactured by Senorx, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K012023 · Senorx, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
76d
Days
Class 2
Risk

K012023 is an FDA 510(k) clearance for the ANCHOR GUIDE LESION LOCALIZATION DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 12, 2001 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K012023

510(k) Number K012023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2001
Decision Date September 12, 2001
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 131d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 365
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K012023.
CARIS MINITOME BIOPSY INSTRUMENT
K020024 · Artemis Medical, Inc. · Apr 2002
TRAPSYSTEM SET
K013692 · H.S. Hospital Service S.R.L. · Feb 2002
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
K012088 · Nastech Pharmaceutical Company, Inc. · Dec 2001
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
K012224 · Ranfac, Corp. · Aug 2001
SPEEDYBELL
K010735 · Biopsybell S.A.S. · Aug 2001
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
K011575 · Imagyn Surgical · Aug 2001
K012023 · ANCHOR GUIDE LESION LOCALIZATION DEVICE
Download PDF FDA Summary Senorx, Inc.