Cleared Traditional

K003528 - SANARUS CORE TISSUE BIOPSY SYSTEM

K003528 is an FDA 510(k) clearance for SANARUS CORE TISSUE BIOPSY SYSTEM, manufactured by Endocare, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K003528 · Endocare, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
168d
Days
Class 2
Risk

K003528 is an FDA 510(k) clearance for the SANARUS CORE TISSUE BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Endocare, Inc. (Irvine, US). The FDA issued a Cleared decision on May 3, 2001 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Endocare, Inc. devices

FDA 510(k) Submission Details - K003528

510(k) Number K003528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2000
Decision Date May 03, 2001
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 130d · This submission: 168d
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 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K003528.
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
K023923 · Senorx, Inc. · Dec 2002
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
K021707 · Senorx, Inc. · Aug 2002
ANCHOR GUIDE LESION LOCALIZATION DEVICE
K012023 · Senorx, Inc. · Sep 2001
MAMMOTOME HAND HELD PROBE, MODEL MHH8
K003297 · Ethicon Endo-Surgery, Inc. · Jan 2001
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · Allegiance Healthcare Corp. · Nov 2000
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
K002546 · CIVCO Medical Instruments Co., Inc. · Oct 2000