Cleared Traditional

FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT (K884275) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 141
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K884275.
MAGNET RETRIEVAL CATHETER
K900852 · Cook, Inc. · May 1990
BARD GASTROSTOMY FEEDING DEVICE
K890870 · C.R. Bard, Inc. · Apr 1989
BARD MOSS(R) GASTROSTOMY TUBE
K890871 · C.R. Bard, Inc. · Apr 1989
DENT SLEEVE MANOMETRIC CATHETER
K881310 · Wilson-Cook Medical, Inc. · May 1988
ENTERAL FEEDING TUBE
K874393 · Wilson-Cook Medical, Inc. · Dec 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · Abbott Laboratories · Aug 1987