Cleared Traditional

K170008 - Osteo-Site Bone Biopsy Needle

K170008 is an FDA 510(k) clearance for Osteo-Site Bone Biopsy Needle, manufactured by Cook Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K170008 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
56d
Days
Class 2
Risk

K170008 is an FDA 510(k) clearance for the Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 28, 2017 after a review of 56 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 Cook Incorporated devices

FDA 510(k) Submission Details - K170008

510(k) Number K170008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date February 28, 2017
Days to Decision 56 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
74d faster than avg
Panel avg: 130d · This submission: 56d
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 198
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K170008.
Bard Mission Disposable Core Biopsy Instrument
K171953 · Bard Peripheral Vascular, Inc. · Sep 2017
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
K171531 · Care Fusion · Sep 2017
Brevera Biopsy System with Corlumina Imaging Technology
K163052 · Hologic, Inc. · Mar 2017
EnCor MRI Introducer Set, EnCor Probe Introducer
K161805 · Senorx, Inc. · Jul 2016
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc. · Mar 2016
Imbibe Needle
K153306 · Orthovita, Inc. · Dec 2015