Cleared Traditional

K150625 - Morrison Steerable Needle

K150625 is an FDA 510(k) clearance for Morrison Steerable Needle, manufactured by Apriomed AB. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K150625 · Apriomed AB · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
90d
Days
Class 2
Risk

K150625 is an FDA 510(k) clearance for the Morrison Steerable Needle. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Apriomed AB (Uppsala, SE). The FDA issued a Cleared decision on June 9, 2015 after a review of 90 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 Apriomed AB devices

FDA 510(k) Submission Details - K150625

510(k) Number K150625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2015
Decision Date June 09, 2015
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 290
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K150625.
Avitus Bone Harvester
K152474 · Avitus Orthopaedics, Inc. · Oct 2015
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
Evacore Fully Disposable Vacuum Assist Biopsy Device
K150088 · Pin-Point Care Corp. · Jul 2015
Marrow Cellution Bone Marrow Aspiration Needle
K150563 · Ranfac, Corp. · May 2015
Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
K141910 · Biologic Therapies, Inc. · May 2015
Imbibe Aspirating XIA Taps
K143546 · Stryker Corporation · Mar 2015