Cleared Traditional

K103694 - TISSUE SAMPLING NEEDLE

K103694 is an FDA 510(k) clearance for TISSUE SAMPLING NEEDLE, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K103694 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Jul 2011
Decision
222d
Days
Class 2
Risk

K103694 is an FDA 510(k) clearance for the TISSUE SAMPLING NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on July 27, 2011 after a review of 222 days - an extended review 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: 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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K103694

510(k) Number K103694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2010
Decision Date July 27, 2011
Days to Decision 222 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 131d · This submission: 222d
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 77
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K103694.
Corvocet Coaxial Introducer
K151373 · Merit Medical Systems, Inc. · Aug 2015
Echotip Procore HD Ultrasound Biopsy Needle
K142688 · Cook Ireland, Ltd. · Dec 2014
SAFETY BIOPSY NEEDLE SYSTEM
K140137 · Pfm Medical, Inc. · Mar 2014
BNX FINE NEEDLE ASPIRATION SYSTEM
K103668 · Boston Endoscopic Engineering · Dec 2010
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