Cleared Traditional

CORE NEEDLE BIOPSY (K040266) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040266 · Remington Medical, Inc. · Gastroenterology & Urology device
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Jul 2004
Decision
155d
Days
Class 2
Risk

K040266 is an FDA 510(k) clearance for the CORE NEEDLE BIOPSY. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 9, 2004 after a review of 155 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 Remington Medical, Inc. devices

Submission Details

510(k) Number K040266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2004
Decision Date July 09, 2004
Days to Decision 155 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 130d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 106
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K040266.
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
K062832 · C.R. Bard, Inc. · Oct 2006
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · Boston Scientific Corp · Jun 2005
MAMMOTOME MR BIOPSY SYSTEM
K042753 · Ethicon Endo-Surgery, Inc. · Nov 2004
MAMMOTOME EX HAND HELD SYSTEM
K033700 · Ethicon Endo-Surgery, Inc. · Feb 2004
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K032943 · Stryker Corp. · Dec 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · Ethicon Endo-Surgery, Inc. · Oct 2003