Cleared Traditional

K141058 - ENSIZOR ENDOSCOPIC SCISSORS

K141058 is an FDA 510(k) clearance for ENSIZOR ENDOSCOPIC SCISSORS, manufactured by Slater Endoscopy, LLC. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K141058 · Slater Endoscopy, LLC · Gastroenterology & Urology device
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Aug 2014
Decision
99d
Days
Class 2
Risk

K141058 is an FDA 510(k) clearance for the ENSIZOR ENDOSCOPIC SCISSORS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Slater Endoscopy, LLC (Melbourne, US). The FDA issued a Cleared decision on August 1, 2014 after a review of 99 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 Slater Endoscopy, LLC devices

FDA 510(k) Submission Details - K141058

510(k) Number K141058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2014
Decision Date August 01, 2014
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
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 47
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K141058.
SimpleSnip Endoscopic Suture Cutter (SC500160)
K242923 · Envision Endoscopy · Dec 2024
Single Use Grasping Forceps
K191900 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2020
Grasping Forceps
K152802 · Micro-Tech (Nanjing) Co., Ltd. · Jan 2016
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