Cleared Traditional

K013069 - BIOSPEED

K013069 is an FDA 510(k) clearance for BIOSPEED, manufactured by H.S. Hospital Services S.P.A.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013069 · H.S. Hospital Services S.P.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
90d
Days
Class 2
Risk

K013069 is an FDA 510(k) clearance for the BIOSPEED. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by H.S. Hospital Services S.P.A. (Boca Raton, US). The FDA issued a Cleared decision on December 12, 2001 after a review of 90 days - within the typical 510(k) review window.

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 H.S. Hospital Services S.P.A. devices

FDA 510(k) Submission Details - K013069

510(k) Number K013069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2001
Decision Date December 12, 2001
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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 K013069.
EASY CORE BIOPSY SYSTEM II
K050120 · Boston Scientific Corp · Feb 2005
EASY CORE BIOPSY SYSTEM
K040893 · Boston Scientific Corp · May 2004
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · Allegiance Healthcare Corp. · Jan 2003
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K012864 · Boston Scientific Corp · Oct 2001
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · Wilson-Cook Medical, Inc. · Oct 2001
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · Olympus America, Inc. · Nov 1999