Product Code: FEG FDA class 2 21 CFR 876.5980

Tube, Double Lumen For Intestinal Decompression And/Or Intubation

Gastroenterology, Urology

The Double Lumen Tube for Intestinal Decompression and/or Intubation (product code FEG) is a dual-channel intestinal tube used to simultaneously decompress bowel obstruction and aspirate intestinal contents, or to facilitate enteral access through a second lumen. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.5980 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FEG
Device Class: FDA class 2
Regulation Number: 876.5980
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171619	14Fr Colon Decompression Set, Macon Colon Decompression Set	Aug 01, 2017	Substantially Equivalent	Cook Ireland, Ltd.
K132314	MEDLINE ANTI-REFLUX VALVE	Sep 18, 2013	Substantially Equivalent	Medline Industries, Inc.
K053410	GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR	Jan 06, 2006	Substantially Equivalent	Kendall
K040388	NEXT GENERATION SALEM SUMP	May 17, 2004	Substantially Equivalent	Kendall
K971354	KNOTT NG TUBE	Nov 19, 1997	Substantially Equivalent	Michael M. Knott, M.D.
K960176	DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER	Jul 24, 1996	Substantially Equivalent	C.R. Bard, Inc.
K926073	ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE	May 15, 1995	Substantially Equivalent	Surgimark, Inc.
K935781	ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY	Jan 27, 1995	Unknown	Sherwood Medical Co.
K921104	LOPEZ VALVE WITH NG SUMP TUBE	Oct 26, 1992	Substantially Equivalent	Icu Medical, Inc.
K900035	WILSON-COOK COLON DECOMPRESSION SET	Mar 07, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K880850	KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE	May 26, 1988	Substantially Equivalent	Kmb Medical Products Co.
K772282	HODGE TUBE	Mar 09, 1978	Substantially Equivalent	Mallinckrodt Critical Care
K771048	CATHETERS, DRAINAGE	Jul 19, 1977	Substantially Equivalent	Axiom Medical, Inc.