Cleared Traditional

K110883 - J-STYLE BONE MARROW BIOPSY / ASPIRATION...

K110883 is an FDA 510(k) clearance for J-STYLE BONE MARROW BIOPSY / ASPIRATION..., manufactured by Busse Hospital Disposables. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K110883 · Busse Hospital Disposables · Gastroenterology & Urology device
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Jun 2011
Decision
70d
Days
Class 2
Risk

K110883 is an FDA 510(k) clearance for the J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITI.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Busse Hospital Disposables (Hauppauge, US). The FDA issued a Cleared decision on June 8, 2011 after a review of 70 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 Busse Hospital Disposables devices

FDA 510(k) Submission Details - K110883

510(k) Number K110883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2011
Decision Date June 08, 2011
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
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 201
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