Product Code: FDA FDA class 2 21 CFR 876.1500

Enteroscope And Accessories

Gastroenterology, Urology

The Enteroscope and Accessories (product code FDA) is an endoscopic instrument used to provide visualization and perform various procedures within the small intestine, including the jejunum and ileum, which are otherwise difficult to access. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. For reusable flexible endoscopes of this type, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FDA
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260314	Ancora-SB	May 01, 2026	Substantially Equivalent	Aspero Medical, Inc.
K251204	FUJIFILM Stiffening Wire Device (SW-2000)	Sep 26, 2025	Substantially Equivalent	FUJIFILM Healthcare Americas Corporation
K233321	Double Balloon Endoscope EN-840T, Over-tube TS-1214C	Jun 13, 2024	Substantially Equivalent	FUJIFILM Healthcare Americas Corporation
K231323	Ancora-SB	Aug 31, 2023	Substantially Equivalent	Aspero Medical, Inc.
K223295	Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D	Jan 11, 2023	Substantially Equivalent	Fujifilm Corporaton
K213195	Balloon BS-3	Oct 29, 2021	Substantially Equivalent	Fujifilm Corporation
K191330	Arc Enterocuff	Jan 31, 2020	Substantially Equivalent	Boddingtons Plastics, Ltd.
K183032	FUJIFILM Double Balloon Endoscope EI580BT	Jun 24, 2019	Substantially Equivalent	Fujifilm Corporation
K183683	FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5	Feb 27, 2019	Substantially Equivalent	Fujifilm Corporation
K143556	Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T	Aug 20, 2015	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K071254	SMALL INTESTINAL VIDEOSCOPE SYSTEM	Mar 25, 2008	Substantially Equivalent	Olympus Medical Systems Corporation
K060923	NAVIAID BGE DEVICE, MODEL 21-001	Aug 15, 2006	Substantially Equivalent	Smart Medical Systems , Ltd.
K060235	ENDO-EASE ENDOSCOPIC OVERTUBE	Aug 04, 2006	Substantially Equivalent	Spirus Medical, Inc.
K040048	FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM	Jun 07, 2004	Substantially Equivalent	Fujinon, Inc.
K031256	XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE	Jul 23, 2003	Substantially Equivalent	Olympus Opto-Electronics Co., Ltd.
K993704	GASTRO-INTESTINAL SYSTEM EN-410WM	Feb 11, 2000	Substantially Equivalent	Fujinon, Inc.
K904800	SIF-SW	Mar 27, 1991	Substantially Equivalent	Olympus Corp.
K840722	ENTEROSCOPE	Jun 07, 1984	Substantially Equivalent	Trimedyne, Inc.
K841396	TRANSFER TROLLEY	May 07, 1984	Substantially Equivalent	Setma, Inc.
K810757	I.V. ADMINISTRATION SET	Apr 08, 1981	Substantially Equivalent	American Mcgaw