Cleared Traditional

K884275 - FLEXIFLO INTRODUCER (DIRECT STICK) GAST...

K884275 is an FDA 510(k) clearance for FLEXIFLO INTRODUCER (DIRECT STICK) GAST..., manufactured by Abbott Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K884275 · Abbott Laboratories · Gastroenterology & Urology device
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Dec 1988
Decision
71d
Days
Class 2
Risk

K884275 is an FDA 510(k) clearance for the FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 71 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 - K884275

510(k) Number K884275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 12, 1988
Decision Date December 22, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
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 344
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K884275.
PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE
K891109 · Concept, Inc. · May 1989
BARD GASTROSTOMY FEEDING DEVICE
K890870 · C.R. Bard, Inc. · Apr 1989
BARD MOSS(R) GASTROSTOMY TUBE
K890871 · C.R. Bard, Inc. · Apr 1989
NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT
K884309 · Biosearch Medical Products, Inc. · Dec 1988
KIM NASO-INTESTINAL TUBE
K882918 · Sheridan Catheter Corp. · Dec 1988
MIC NEEDLE JEJUNOSTOMY TUBE KIT
K880767 · Medical Innovations Corp. · Aug 1988