Cleared Traditional

K182403 - Peel-Away Introducer

K182403 is the FDA 510(k) clearance for Peel-Away Introducer by Cook Incorporated. It is a Class 2 Gastroenterology & Urology device (product code FED) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K182403 · Cook Incorporated · Gastroenterology & Urology device
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May 2019
Decision
267d
Days
Class 2
Risk

K182403 is an FDA 510(k) clearance for the Peel-Away Introducer. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 29, 2019 after a review of 267 days - an extended review 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: 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 Cook Incorporated devices

Submission Details

510(k) Number K182403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date May 29, 2019
Days to Decision 267 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
137d slower than avg
Panel avg: 130d · This submission: 267d
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 62
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K182403.
PatCom Single-Use Introducer
K192691 · H&A Mui Enterprises, Inc. · Feb 2020
Pathfinder Endoscope Overtube
K191415 · Neptune Medical, Inc. · Aug 2019
Arc Endocuff Glide AEG110 & AEG120
K191067 · Boddingtons Plastics, Ltd. · May 2019
Flexible Overtube
K182520 · Sumitomo Bakelite Co., Ltd. · May 2019
Embrella Endoscopic Distal Attachment
K190030 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2019
ReTrace Ureteral Access Sheath
K181811 · Coloplast A/S · Sep 2018