Cleared Traditional

K071191 - NOVARTIS COMPAT SURGICAL GASTROSTOMY JE...

K071191 is an FDA 510(k) clearance for NOVARTIS COMPAT SURGICAL GASTROSTOMY JE..., manufactured by Novartis Nutrition Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K071191 · Novartis Nutrition Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
84d
Days
Class 2
Risk

K071191 is an FDA 510(k) clearance for the NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Novartis Nutrition Corp. (St. Louis Park, US). The FDA issued a Cleared decision on July 23, 2007 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Novartis Nutrition Corp. devices

FDA 510(k) Submission Details - K071191

510(k) Number K071191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date July 23, 2007
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FPD Device Classification - Class 2, Special Controls

Product Code FPD Tube, Feeding
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 - FPD Tube, Feeding

All 20
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K071191.
NUTRISAFE 2 FEEDING TUBE
K121105 · Vygon Corp. · Dec 2012
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
K100163 · Vygon Corp. · Oct 2011
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp · Jun 2009
NUTRISAFE 2
K060944 · Vygon Corp. · Sep 2006
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · Vygon Corp. · Jan 2002
JEJENOSTOMY FEEDING TUBE
K971906 · Boston Scientific Corp · Aug 1997