Cleared Traditional

K081323 - BIOPSY GUIDE KIT FOR 8808 AND BIPLANE

K081323 is an FDA 510(k) clearance for BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, manufactured by B-K Medical Aps. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K081323 · B-K Medical Aps · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
71d
Days
Class 2
Risk

K081323 is an FDA 510(k) clearance for the BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by B-K Medical Aps (Herlev, DK). The FDA issued a Cleared decision on July 22, 2008 after a review of 71 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.

View all B-K Medical Aps devices

FDA 510(k) Submission Details - K081323

510(k) Number K081323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2008
Decision Date July 22, 2008
Days to Decision 71 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
59d faster than avg
Panel avg: 130d · This submission: 71d
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 K081323.
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · Boston Scientific Corporation · Mar 2010
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