Cleared Traditional

K133736 - ENDOSCOPIC SUTURE CUTTER

K133736 is an FDA 510(k) clearance for ENDOSCOPIC SUTURE CUTTER, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K133736 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Jan 2014
Decision
29d
Days
Class 2
Risk

K133736 is an FDA 510(k) clearance for the ENDOSCOPIC SUTURE CUTTER. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on January 7, 2014 after a review of 29 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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K133736

510(k) Number K133736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2013
Decision Date January 07, 2014
Days to Decision 29 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 131d · This submission: 29d
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 55
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K133736.
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