Cleared Traditional

K171953 - Bard Mission Disposable Core Biopsy Ins...

K171953 is the FDA 510(k) clearance for Bard Mission Disposable Core Biopsy Ins... by Bard Peripheral Vascular, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K171953 · Bard Peripheral Vascular, Inc. · Gastroenterology & Urology device
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Sep 2017
Decision
77d
Days
Class 2
Risk

K171953 is an FDA 510(k) clearance for the Bard Mission Disposable Core Biopsy Instrument. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on September 14, 2017 after a review of 77 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 Bard Peripheral Vascular, Inc. devices

Submission Details

510(k) Number K171953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2017
Decision Date September 14, 2017
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 110
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K171953.
Corvocet Biopsy System
K180450 · Merit Medical Systems, Inc. · Mar 2018
Stryker iVAS 13g Bone Biopsy Kit
K180327 · Stryker Corporation · Feb 2018
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
K172558 · Stryker Corporation · Oct 2017
Brevera Biopsy System with Corlumina Imaging Technology
K163052 · Hologic, Inc. · Mar 2017
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
K170008 · Cook Incorporated · Feb 2017
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc. · Mar 2016