Cleared Special

K051361 - EASY CORE DETACHABLE BIOPSY SYSTEM

K051361 is an FDA 510(k) clearance for EASY CORE DETACHABLE BIOPSY SYSTEM, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 22-day FDA review.

K051361 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jun 2005
Decision
22d
Days
Class 2
Risk

K051361 is an FDA 510(k) clearance for the EASY CORE DETACHABLE BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on June 16, 2005 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K051361

510(k) Number K051361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2005
Decision Date June 16, 2005
Days to Decision 22 days
Submission Type Special
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
109d faster than avg
Panel avg: 131d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 290
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K051361.
I-STYLE BONE MARROW ASPIRATION NEEDLE
K061570 · Busse Hospital Disposables, Inc. · Jul 2006
MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
K052802 · Manan Medical Products, Inc. · Nov 2005
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
K051581 · Sanarus Medical, Inc. · Jul 2005
IMBIBE BONE MARROW ASPIRATION NEEDLE
K050795 · Orthovita, Inc. · Jun 2005
ENCOR 7 GAUGE
K051158 · Senorx, Inc. · May 2005
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
K043523 · Medical Device Technologies, Inc. · Feb 2005