Cleared Traditional

K072684 - MONDEAL ENDOSCOPIC TISSUE RECESSION AND...

K072684 is an FDA 510(k) clearance for MONDEAL ENDOSCOPIC TISSUE RECESSION AND..., manufactured by Mondeal North America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K072684 · Mondeal North America, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 2008
Decision
105d
Days
Class 2
Risk

K072684 is an FDA 510(k) clearance for the MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Mondeal North America, Inc. (San Diego, US). The FDA issued a Cleared decision on January 4, 2008 after a review of 105 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 Mondeal North America, Inc. devices

FDA 510(k) Submission Details - K072684

510(k) Number K072684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date January 04, 2008
Days to Decision 105 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
25d faster than avg
Panel avg: 130d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCZ Device Classification - Class 2, Special Controls

Product Code OCZ Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.
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 - OCZ Endoscopic Grasping/cutting Instrument, Non-powered

All 39
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K072684.
ENDOSCOPIC SUTURE CUTTER
K133736 · United States Endoscopy Group, Inc. · Jan 2014
ENDOSCOPIC RETRIEVAL DEVICE
K120084 · United States Endoscopy Group, Inc. · May 2012
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
K101298 · Endochoice, Inc. · Aug 2010
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
K051276 · Richard Wolf Medical Instruments Corp. · Oct 2005
STONE EXTRACTOR
K971123 · Phx Technologies Corp. · Jun 1997
OLYMPUS BASKET GRASPERS (UROLOGY)
K961611 · Olympus America, Inc. · Jul 1996