Cleared Traditional

K050135 - K-C HEMOSTATIC BIOPSY SYSTEM

K050135 is an FDA 510(k) clearance for K-C HEMOSTATIC BIOPSY SYSTEM, manufactured by Bioengineering Consultants , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K050135 · Bioengineering Consultants , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
173d
Days
Class 2
Risk

K050135 is an FDA 510(k) clearance for the K-C HEMOSTATIC BIOPSY SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Bioengineering Consultants , Ltd. (Charlottesville, US). The FDA issued a Cleared decision on July 13, 2005 after a review of 173 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 Bioengineering Consultants , Ltd. devices

FDA 510(k) Submission Details - K050135

510(k) Number K050135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2005
Decision Date July 13, 2005
Days to Decision 173 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
43d slower than avg
Panel avg: 130d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

Product Code FCG Biopsy Needle
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 - FCG Biopsy Needle

All 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K050135.
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
K093195 · Cook Ireland, Ltd. · Jan 2010
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
K092359 · Cook Ireland, Ltd. · Nov 2009
TROKABONE, TROKABONE STERNAL
K070179 · PAJUNK GmbH Medizintechnologie · Mar 2007
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
K050503 · Olympus Medical Systems Corporation · May 2005
EASY CORE BIOPSY SYSTEM II
K050120 · Boston Scientific Corp · Feb 2005
EASY CORE BIOPSY SYSTEM
K040893 · Boston Scientific Corp · May 2004