Cleared Traditional

K021525 - TOPCUT

K021525 is an FDA 510(k) clearance for TOPCUT, manufactured by H.S. Hospital Service S.R.L.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K021525 · H.S. Hospital Service S.R.L. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
63d
Days
Class 2
Risk

K021525 is an FDA 510(k) clearance for the TOPCUT. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by H.S. Hospital Service S.R.L. (Boca Raton, US). The FDA issued a Cleared decision on July 12, 2002 after a review of 63 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 H.S. Hospital Service S.R.L. devices

FDA 510(k) Submission Details - K021525

510(k) Number K021525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date July 12, 2002
Days to Decision 63 days
Submission Type Traditional
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
68d faster than avg
Panel avg: 131d · This submission: 63d
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 103
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K021525.
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · Allegiance Healthcare Corp. · Jan 2003
DISPOSABLE ASPIRATION NEEDLE NA-200H
K023272 · The Olympus Optical Co. · Dec 2002
BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
K021847 · Biopsy Sciences, LLC · Sep 2002
SONOPSY
K013109 · Hakko Medical Co., Ltd. · Mar 2002
BIOSPEED
K013069 · H.S. Hospital Services S.P.A. · Dec 2001
JAMSHIDI BIOPSY NEEDLE
K013070 · H.S. Hospital Services S.P.A. · Dec 2001