Cleared Special

K161167 - Seal Single-Use Biopsy Valve

K161167 is an FDA 510(k) clearance for Seal Single-Use Biopsy Valve, manufactured by Endochoice, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Special 510(k) pathway after a 30-day FDA review.

K161167 · Endochoice, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
30d
Days
Class 2
Risk

K161167 is an FDA 510(k) clearance for the Seal Single-Use Biopsy Valve. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on May 26, 2016 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161167

510(k) Number K161167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2016
Decision Date May 26, 2016
Days to Decision 30 days
Submission Type Special
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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OCX Device Classification - Class 2, Special Controls

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 88
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K161167.
Endorate Valve Sets
K181509 · Smartdata Suzhou Co., Ltd. · Jul 2018
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K173758 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · May 2018
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K171637 · Cipher Surgical, Ltd. · Feb 2018
ENDOFLOW II - Irrigation, Warming and Suction System
K152278 · Promepla Sam · Feb 2016
Boa Endoscopic Valve
K152140 · C2 Therapeutics, Inc. · Oct 2015
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON
K142068 · Medovations, Inc. · Mar 2015