Cleared Traditional

K143546 - Imbibe Aspirating XIA Taps

K143546 is an FDA 510(k) clearance for Imbibe Aspirating XIA Taps, manufactured by Stryker Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K143546 · Stryker Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
94d
Days
Class 2
Risk

K143546 is an FDA 510(k) clearance for the Imbibe Aspirating XIA Taps. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on March 19, 2015 after a review of 94 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 Stryker Corporation devices

FDA 510(k) Submission Details - K143546

510(k) Number K143546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date March 19, 2015
Days to Decision 94 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
37d faster than avg
Panel avg: 131d · This submission: 94d
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 215
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K143546.
K2M Fenestrated Tap System
K152872 · K2m · Jan 2016
Imbibe Needle
K153306 · Orthovita, Inc. · Dec 2015
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
K141552 · Care Fusion · Sep 2014
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · Stryker Corporation · Sep 2014
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
K133948 · Bard Peripheral Vascular, Inc. · Feb 2014