Cleared Traditional

Entuit Start Initial Placement Gastrostomy Set (K170323) - FDA 510(k) Clearance

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

K170323 · Cook Incorporated · Gastroenterology & Urology device
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Sep 2017
Decision
225d
Days
Class 2
Risk

K170323 is an FDA 510(k) clearance for the Entuit Start Initial Placement Gastrostomy Set. Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 14, 2017 after a review of 225 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 K170323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2017
Decision Date September 14, 2017
Days to Decision 225 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
95d slower than avg
Panel avg: 130d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGC Tube, Gastro-enterostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KGC Tube, Gastro-enterostomy

All 11
Devices cleared under the same product code (KGC) and FDA review panel - the closest regulatory comparables to K170323.
Fidmi Low Profile Enteral Feeding Device
K191844 · Fidmi Medical, Ltd. · Sep 2019
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
K182832 · Cook Incorporated · Jun 2019
PUMA-G System
K183057 · Coaptech, LLC · Apr 2019
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
K093312 · Kimberly-Clark Corp. · Dec 2009
MEDLINE GASTROSTOMY TUBE
K073718 · Medline Industries, Inc. · Mar 2008
KIMBERLY-CLARK INTRODUCER KITS
K080253 · Kimberly-Clark Corp. · Feb 2008