Cleared Traditional

PatCom Single-Use Introducer (K192691) - FDA 510(k) Clearance

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

K192691 · H&A Mui Enterprises, Inc. · Gastroenterology & Urology device
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Feb 2020
Decision
148d
Days
Class 2
Risk

K192691 is an FDA 510(k) clearance for the PatCom Single-Use Introducer. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by H&A Mui Enterprises, Inc. (Mississauga, CA). The FDA issued a Cleared decision on February 21, 2020 after a review of 148 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 H&A Mui Enterprises, Inc. devices

Submission Details

510(k) Number K192691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date February 21, 2020
Days to Decision 148 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 130d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 48
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K192691.
ClearPetra Suction-Evacuation Sheath
K203119 · Well Lead Medical Co., Ltd. · Dec 2020
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Kalera Vacuum Aspiration Catheter (K-VAC)
K200419 · Kalera Medical, Inc. · May 2020
Pathfinder Endoscope Overtube
K191415 · Neptune Medical, Inc. · Aug 2019
Arc Endocuff Glide AEG110 & AEG120
K191067 · Boddingtons Plastics, Ltd. · May 2019
Peel-Away Introducer
K182403 · Cook Incorporated · May 2019