Cleared Special

K120126 - BAROSENSE ENDOGASTRIC TUBE AND INTRODUC...

K120126 is an FDA 510(k) clearance for BAROSENSE ENDOGASTRIC TUBE AND INTRODUC..., manufactured by Barosense, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Special 510(k) pathway after a 237-day FDA review.

K120126 · Barosense, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
237d
Days
Class 2
Risk

K120126 is an FDA 510(k) clearance for the BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Barosense, Inc. (Redwood City, US). The FDA issued a Cleared decision on September 10, 2012 after a review of 237 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Barosense, Inc. devices

FDA 510(k) Submission Details - K120126

510(k) Number K120126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date September 10, 2012
Days to Decision 237 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 130d · This submission: 237d
Pathway characteristics
Modification to existing cleared device.

FED Device Classification - Class 2, Special Controls

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 67
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K120126.
ANAL RECTAL OVERTUBE
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