Cleared Traditional

K020987 - BMN I TYPE MARROW ASPIRATION NEEDLE

K020987 is an FDA 510(k) clearance for BMN I TYPE MARROW ASPIRATION NEEDLE, manufactured by H.S. Hospital Service S.R.L.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020987 · H.S. Hospital Service S.R.L. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2002
Decision
90d
Days
Class 2
Risk

K020987 is an FDA 510(k) clearance for the BMN I TYPE MARROW ASPIRATION NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by H.S. Hospital Service S.R.L. (Boca Raton, US). The FDA issued a Cleared decision on June 25, 2002 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 Service S.R.L. devices

FDA 510(k) Submission Details - K020987

510(k) Number K020987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2002
Decision Date June 25, 2002
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
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 - KNW Instrument, Biopsy

All 323
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K020987.
NAFD 100
K020848 · Neomatrix, LLC · Sep 2002
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
K021707 · Senorx, Inc. · Aug 2002
SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM
K021137 · Sanarus Medical, Inc. · Jun 2002
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
K020867 · Worldwide Medical Technologies, LLC · May 2002
BIOSUC
K013108 · Hakko Medical Co., Ltd. · Apr 2002
CARIS MINITOME BIOPSY INSTRUMENT
K020024 · Artemis Medical, Inc. · Apr 2002