Cleared Traditional

K171956 - Sterile Endoscope Biopsy Sampling Needle

K171956 is an FDA 510(k) clearance for Sterile Endoscope Biopsy Sampling Needle, manufactured by Changzhou Detain Medical Devices Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K171956 · Changzhou Detain Medical Devices Co., Ltd. · Gastroenterology & Urology device
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Dec 2017
Decision
166d
Days
Class 2
Risk

K171956 is an FDA 510(k) clearance for the Sterile Endoscope Biopsy Sampling Needle. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Changzhou Detain Medical Devices Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 12, 2017 after a review of 166 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 Changzhou Detain Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K171956

510(k) Number K171956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2017
Decision Date December 12, 2017
Days to Decision 166 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
36d slower than avg
Panel avg: 130d · This submission: 166d
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 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K171956.
Single Use Aspiration Needle NA-U201H
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K180037 · Covidien, LLC · Apr 2018
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
K171596 · Wilson-Cook Medical, Inc. · Aug 2017
Howell Biliary Introducer Needle
K160890 · Wilson-Cook Medical, Inc. · Jun 2017
Single Use Aspiration Needle NA-U401SX
K160098 · Olympus Medical Systems Corp. · Mar 2016