Cleared Traditional

K143088 - GastriSail Gastric Positioning System

K143088 is an FDA 510(k) clearance for GastriSail Gastric Positioning System, manufactured by Covidien. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K143088 · Covidien · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
120d
Days
Class 2
Risk

K143088 is an FDA 510(k) clearance for the GastriSail Gastric Positioning System. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on February 25, 2015 after a review of 120 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K143088

510(k) Number K143088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2014
Decision Date February 25, 2015
Days to Decision 120 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
11d faster than avg
Panel avg: 131d · This submission: 120d
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 537
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K143088.
MIDSLEEVE
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AbbVie PEG
K142793 · AbbVie, Inc. · Jan 2015
AbbVie J
K142816 · AbbVie, Inc. · Jan 2015
K143088 · GastriSail Gastric Positioning System
Download PDF FDA Summary Covidien