Cleared Special

K133734 - SEAL SINGLE-USE BIOPSY VALVE

K133734 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 100-day FDA review.

K133734 · Endochoice, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
100d
Days
Class 2
Risk

K133734 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 March 19, 2014 after a review of 100 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K133734

510(k) Number K133734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2013
Decision Date March 19, 2014
Days to Decision 100 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
31d faster than avg
Panel avg: 131d · This submission: 100d
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 K133734.
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
K143186 · Erbe USA, Inc. · Dec 2014
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
K140753 · Medivators · Jul 2014
US ENDOSCOPY DISTAL ATTACHMENT CAP
K140315 · United States Endoscopy Group, Inc. · Apr 2014
TORRENT IRRIGATION SYSTEM
K140405 · United States Endoscopy Group, Inc. · Mar 2014
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc. · Feb 2014
SEAL BIOPSY VALVE - REUSABLE
K132776 · Endochoice, Inc. · Dec 2013