Cleared Traditional

K111821 - BIOPSY VALVE

K111821 is an FDA 510(k) clearance for BIOPSY VALVE, 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 30-day FDA review.

K111821 · Endochoice, Inc. · Gastroenterology & Urology device
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Jul 2011
Decision
30d
Days
Class 2
Risk

K111821 is an FDA 510(k) clearance for the 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 July 28, 2011 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. 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 Endochoice, Inc. devices

FDA 510(k) Submission Details - K111821

510(k) Number K111821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2011
Decision Date July 28, 2011
Days to Decision 30 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
101d faster than avg
Panel avg: 131d · This submission: 30d
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 K111821.
CLEARPATH 24
K112318 · Promedic, Inc. · Jun 2012
ENDOGATOR ADVANTAGE IRRIGATION PUMP
K113119 · Byrne Medical, Inc. · Apr 2012
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
K111274 · Jetprep, Ltd. · Apr 2012
IRRIGATION SYSTEM
K103239 · United States Endoscopy Group, Inc. · Dec 2010
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
K103235 · Erbe USA, Inc. · Dec 2010
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
K092461 · United States Endoscopy Group, Inc. · Nov 2009