Cleared Traditional

K132776 - SEAL BIOPSY VALVE - REUSABLE

K132776 is an FDA 510(k) clearance for SEAL BIOPSY VALVE - REUSABLE, manufactured by Endochoice, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K132776 · Endochoice, Inc. · Gastroenterology & Urology device
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Dec 2013
Decision
106d
Days
Class 2
Risk

K132776 is an FDA 510(k) clearance for the SEAL BIOPSY VALVE - REUSABLE. 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 December 20, 2013 after a review of 106 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. 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 Endochoice, Inc. devices

FDA 510(k) Submission Details - K132776

510(k) Number K132776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2013
Decision Date December 20, 2013
Days to Decision 106 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
25d faster than avg
Panel avg: 131d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 81
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K132776.
SEAL SINGLE-USE BIOPSY VALVE
K133734 · Endochoice, Inc. · Mar 2014
TORRENT IRRIGATION SYSTEM
K140405 · United States Endoscopy Group, Inc. · Mar 2014
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc. · Feb 2014
SCOPEVALET DISPOSABLE BIOPSY VALVE
K122417 · The Ruhof Corp. · May 2013
GATEWAY ADVANAGE Y-ADAPTER
K130909 · Boston Scientific Corp · May 2013
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K122740 · Jetprep, Ltd. · Dec 2012