Cleared Traditional

K083330 - ECHOTIP ULTRA ULTRASOUND NEEDLE

K083330 is an FDA 510(k) clearance for ECHOTIP ULTRA ULTRASOUND NEEDLE, manufactured by Cook Endoscopy. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K083330 · Cook Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
86d
Days
Class 2
Risk

K083330 is an FDA 510(k) clearance for the ECHOTIP ULTRA ULTRASOUND NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 86 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 Endoscopy devices

FDA 510(k) Submission Details - K083330

510(k) Number K083330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date February 06, 2009
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 131d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

Product Code FCG Biopsy Needle
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 - FCG Biopsy Needle

All 86
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K083330.
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · Boston Scientific Corporation · Mar 2010
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
K093195 · Cook Ireland, Ltd. · Jan 2010
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
K092359 · Cook Ireland, Ltd. · Nov 2009
TROKABONE, TROKABONE STERNAL
K070179 · PAJUNK GmbH Medizintechnologie · Mar 2007
MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
K051506 · Sterylab S.R.L. · Jul 2005
K-C HEMOSTATIC BIOPSY SYSTEM
K050135 · Bioengineering Consultants , Ltd. · Jul 2005