Cleared Traditional

San Antonio Stopcock (K181712) - FDA 510(k) Clearance

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

K181712 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
28d
Days
Class 2
Risk

K181712 is an FDA 510(k) clearance for the San Antonio Stopcock. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 26, 2018 after a review of 28 days - a notably fast clearance 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: 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 Incorporated devices

Submission Details

510(k) Number K181712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2018
Decision Date July 26, 2018
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 49
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K181712.
Bio Guard Air/Water & Suction Valves
K192059 · United States Endoscopy Group, Inc. · Sep 2019
Andorate Auxiliary Water Connector, Andorate Valves Set
K191231 · Smartdata Suzhou Co., Ltd. · Jun 2019
CleverLock Guidewire Locking Device and Biopsy Cap
K190164 · Olympus Surgical Technologies America · Apr 2019
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
K173105 · Cook Incorporated · Mar 2018
Accessory Irrigation Adapter
K162142 · Wilson-Cook Medical, Inc. · Apr 2017
BioGuard Air/Water Valve, BioGuard Suction Valve
K151345 · United States Endoscopy Group, Inc. · Aug 2015