Cleared Traditional

Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set (K170008) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170008 · Cook Incorporated · Gastroenterology & Urology device
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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

Submission Details

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.

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 106
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K170008.
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
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc. · Mar 2016
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
K111100 · C.R. Bard, Inc. · Jun 2011