Cleared Traditional

K121181 - SWANNSHIDI BONE MARROW ASPIRATION NEEDLE

K121181 is an FDA 510(k) clearance for SWANNSHIDI BONE MARROW ASPIRATION NEEDLE, manufactured by Alliance Partners, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K121181 · Alliance Partners, LLC · Gastroenterology & Urology device
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Aug 2012
Decision
126d
Days
Class 2
Risk

K121181 is an FDA 510(k) clearance for the SWANNSHIDI BONE MARROW ASPIRATION NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Alliance Partners, LLC (Avon Lake, US). The FDA issued a Cleared decision on August 22, 2012 after a review of 126 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 Alliance Partners, LLC devices

FDA 510(k) Submission Details - K121181

510(k) Number K121181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2012
Decision Date August 22, 2012
Days to Decision 126 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
5d faster than avg
Panel avg: 131d · This submission: 126d
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 272
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K121181.
REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
K130282 · Remington Medical, Inc. · May 2013
CASSI II ROTATIONAL CORE BIOPSY SYSTEM
K123606 · Scion Medical Technologies, LLC · Mar 2013
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
K123259 · Devicor Medical Products, Inc. · Nov 2012
I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
K120002 · Busse Hospital Disposables, Inc. · Jun 2012
PRESTO BREAST BIOPSY DEVICE
K120440 · Sontina Medical, LLC · May 2012
MAMMOTOME ELITE BIOPSY SYSTEM
K112411 · Devicor Medical Products, Inc. · Mar 2012