Cleared Traditional

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 (K081323) - FDA 510(k) Clearance

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

K081323 · B-K Medical Aps · Gastroenterology & Urology device
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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

Submission Details

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.

Device Classification

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 30
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K081323.
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