Cleared Traditional

Disposable Biopsy Valve (K173758) - FDA 510(k) Clearance

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

K173758 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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May 2018
Decision
154d
Days
Class 2
Risk

K173758 is an FDA 510(k) clearance for the Disposable Biopsy Valve. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hanzhou, CN). The FDA issued a Cleared decision on May 14, 2018 after a review of 154 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Zhejiang Chuangxiang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K173758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2017
Decision Date May 14, 2018
Days to Decision 154 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
24d slower than avg
Panel avg: 130d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
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 - OCX Endoscopic Irrigation/suction System

All 50
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K173758.
ERBEFLO Olympus Scope Port Connector
K182444 · Erbe USA, Inc. · Nov 2018
Seal Single Use Biopsy Valve
K182275 · Boston Scientific Corporation · Sep 2018
Endorate Valve Sets
K181509 · Smartdata Suzhou Co., Ltd. · Jul 2018
OpClear System
K171637 · Cipher Surgical, Ltd. · Feb 2018
US ENDOSCOPY DISTAL ATTACHMENT CAP
K140315 · United States Endoscopy Group, Inc. · Apr 2014
TORRENT IRRIGATION SYSTEM
K140405 · United States Endoscopy Group, Inc. · Mar 2014