Cleared Traditional

K122417 - SCOPEVALET DISPOSABLE BIOPSY VALVE

K122417 is an FDA 510(k) clearance for SCOPEVALET DISPOSABLE BIOPSY VALVE, manufactured by The Ruhof Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K122417 · The Ruhof Corp. · Gastroenterology & Urology device
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May 2013
Decision
282d
Days
Class 2
Risk

K122417 is an FDA 510(k) clearance for the SCOPEVALET DISPOSABLE BIOPSY VALVE. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by The Ruhof Corp. (Austin, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 282 days - an extended review 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: 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 The Ruhof Corp. devices

FDA 510(k) Submission Details - K122417

510(k) Number K122417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2012
Decision Date May 17, 2013
Days to Decision 282 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 130d · This submission: 282d
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 66
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K122417.
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
GATEWAY ADVANAGE Y-ADAPTER
K130909 · Boston Scientific Corp · May 2013
BIOPSY VALVE
K111821 · Endochoice, Inc. · Jul 2011
IRRIGATION SYSTEM
K103239 · United States Endoscopy Group, Inc. · Dec 2010