Product Code: MND FDA class 2 21 CFR 876.4400

Ligator, Esophageal

Gastroenterology, Urology

The Esophageal Ligator is an endoscopic device used during upper gastrointestinal endoscopy to apply elastic bands around esophageal varices or other mucosal lesions, causing them to necrose and slough off, thereby treating bleeding varices and reducing the risk of life-threatening hemorrhage in patients with portal hypertension. Classified as a Class 2 device under 21 CFR 876.4400 within the Gastroenterology and Urology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MND
Device Class: FDA class 2
Regulation Number: 876.4400
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132535	AUTOBAND LIGATOR	Aug 23, 2013	Substantially Equivalent	Endochoice, Inc.
K083556	MODIFICATION TO AUTO-BAND LIGATOR	Feb 19, 2009	Substantially Equivalent	Scandimed International
K081142	AUTO-BAND LIGATOR	May 16, 2008	Substantially Equivalent	Scandimed International
K051950	INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321	Oct 07, 2005	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K031236	AUTO-BAND LIGATOR	Nov 14, 2003	Substantially Equivalent	Scandimed. A.S.
K033245	BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U	Nov 06, 2003	Substantially Equivalent	C.R. Bard, Inc.
K022434	BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U	Aug 05, 2002	Substantially Equivalent	C.R. Bard, Inc.
K013066	HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE	Dec 11, 2001	Substantially Equivalent	Olympus America, Inc.
K001744	OLYMPUS ENDOSCOPIC LIGATION DEVICE	Feb 27, 2001	Substantially Equivalent	Olympus America, Inc.
K990864	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228	Jun 11, 1999	Substantially Equivalent	Boston Scientific Corp
K984255	OLYMPUS HX-20 SERIES LIGATING DEVICE	Jan 12, 1999	Substantially Equivalent	Olympus Corp of America
K964661	HX-20/21-1 ENDOSCOPIC LIGATOR	Oct 30, 1997	Substantially Equivalent	Olympus America, Inc.
K971137	BARD RAPIDFIRE MULTIPLE BAND LIGATOR	Oct 16, 1997	Substantially Equivalent	C.R. Bard, Inc.
K944220	WILSON COOK MULTIPLE BAND LIGATOR	Jan 24, 1995	Substantially Equivalent	Wilson-Cook Medical, Inc.
K940661	STIEGMANN-GOFF ENDOSCOPIC LIGATOR	Nov 28, 1994	Substantially Equivalent	C.R. Bard, Inc.