Cleared Traditional

K160509 - Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube

K160509 is an FDA 510(k) clearance for Tiger 2 Self-Advancing Nasal Jejunal Fe..., manufactured by Cook Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K160509 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
449d
Days
Class 2
Risk

K160509 is an FDA 510(k) clearance for the Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 18, 2017 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Cook Incorporated devices

FDA 510(k) Submission Details - K160509

510(k) Number K160509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 24, 2016
Decision Date May 18, 2017
Days to Decision 449 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
318d slower than avg
Panel avg: 131d · This submission: 449d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 524
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K160509.
Stomach Tube
K162340 · Well Lead Medical Co., Ltd. · Oct 2017
Low Profile Non-Balloon Feeding Device
K170319 · Applied Medical Technology, Inc. · Oct 2017
Navina Classic System
K170487 · Dentsply Sirona · Sep 2017
Barone Jejunostomy Catheter Set
K160567 · Cook Incorporated · May 2017
Kangaroo Feeding Tube with IRIS Technology
K163002 · Covidien (Dba Medtronic) · May 2017
Flexi-Seal PROTECT Fecal Management System
K162906 · Convatec · Mar 2017