Cleared Traditional

K912972 - FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEE...

K912972 is an FDA 510(k) clearance for FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEE..., manufactured by Abbott Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K912972 · Abbott Laboratories · Gastroenterology & Urology device
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Sep 1991
Decision
77d
Days
Class 2
Risk

K912972 is an FDA 510(k) clearance for the FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 77 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K912972

510(k) Number K912972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date September 23, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K912972.
RUSCH ENTERAL FEEDING TUBE
K963779 · Rusch, Inc. · May 1997
STERILE FEEDING TUBE
K954218 · Baxter Healthcare Corp · Nov 1995
STOMA MEASURING DEVICE
K914482 · Biosearch Medical Products, Inc. · Dec 1991
WILSON-COOK PULL THROUGH PEG KIT
K901163 · Wilson-Cook Medical, Inc. · Nov 1990
INFANT FEEDING TUBE
K896559 · Westmark, Sterile Packing Systems, Inc. (Sps) · Mar 1990
KENDALL CURITY FEEDING TUBES
K892431 · The Kendal Co. · May 1989