Cleared Traditional

K130611 - ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE

K130611 is an FDA 510(k) clearance for ENTUIT THRIVE BALLOON RETENTION GASTROS..., manufactured by Xeridiem Medical Devices. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K130611 · Xeridiem Medical Devices · Gastroenterology & Urology device
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Dec 2013
Decision
287d
Days
Class 2
Risk

K130611 is an FDA 510(k) clearance for the ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Xeridiem Medical Devices (Tucson, US). The FDA issued a Cleared decision on December 19, 2013 after a review of 287 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 Xeridiem Medical Devices devices

FDA 510(k) Submission Details - K130611

510(k) Number K130611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date December 19, 2013
Days to Decision 287 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
156d slower than avg
Panel avg: 131d · This submission: 287d
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 513
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K130611.
METRIXCARE
K132424 · The Metrix Company · Feb 2014
MACY CATHETER
K133881 · Hospi Corporation · Jan 2014
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130674 · Xeridiem Medical Devices · Jan 2014
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
K131052 · Actuated Medical, Inc. · Aug 2013
ELECTROMAGNETIC TRANSMITTING STYLET
K131532 · Corpak Medsystems · Aug 2013
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
K122653 · Kimberly Clark Corporation · Jun 2013