Cleared Traditional

FLEXIFLO SACKS-VINE GASTROSTOMY KITS (K910332) - FDA 510(k) Clearance

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

K910332 · Abbott Laboratories · Gastroenterology & Urology device

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Mar 1991

Decision

53d

Days

Class 2

Risk

K910332 is an FDA 510(k) clearance for the FLEXIFLO SACKS-VINE GASTROSTOMY KITS. 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 March 19, 1991 after a review of 53 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	K910332 FDA.gov
FDA Decision	Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received	January 25, 1991
Decision Date	March 19, 1991
Days to Decision	53 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

77d faster than avg

Panel avg: 130d · This submission: 53d

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 K910332.

ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE

K900623 · Wilson-Cook Medical, Inc. · Oct 1991

WILSON-COOK RUSSELL GASTROSTOMY KIT

K912047 · Wilson-Cook Medical, Inc. · Sep 1991

FLEXIFLO ENTERAL FEEDING TUBE

K910382 · Abbott Laboratories · Aug 1991

FLEXIFLO STOMATE EXTENSION TUBE

K902623 · Abbott Laboratories · Jan 1991

FLEXIFLO STOMATE DECOMPRESSION TUBE

K903579 · Abbott Laboratories · Nov 1990

FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT

K903325 · Abbott Laboratories · Nov 1990

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K910332

Abbott Laboratories

Columbus, OH · US

MICHAEL H HANEY

Regulatory profile

883 submissions 868 cleared

98% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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