Cleared Traditional

MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM (K072684) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072684 · Mondeal North America, Inc. · Gastroenterology & Urology device
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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

Submission Details

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.

Device Classification

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 73
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K072684.
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K950434 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
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K881332 · Baxter Healthcare Corp · Apr 1988
DAVOL RETRIEVAL BASKETS & FORCEPS
K845017 · C.R. Bard, Inc. · Jan 1985