Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4400](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4400) → MND — Ligator, Esophageal

# MND · Ligator, Esophageal

_Gastroenterology, Urology · 21 CFR 876.4400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND

## Overview

- **Product Code:** MND
- **Device Name:** Ligator, Esophageal
- **Regulation:** [21 CFR 876.4400](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4400)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

## Classification Rationale

Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Special Controls

*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K132535](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K132535.md) | AUTOBAND LIGATOR | Endochoice, Inc. | Aug 23, 2013 | SESE |
| [K083556](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K083556.md) | MODIFICATION TO AUTO-BAND LIGATOR | Scandimed International | Feb 19, 2009 | SESE |
| [K081142](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K081142.md) | AUTO-BAND LIGATOR | Scandimed International | May 16, 2008 | SESE |
| [K051950](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K051950.md) | INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 | Ethicon Endo-Surgery, Inc. | Oct 7, 2005 | SESE |
| [K031236](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K031236.md) | AUTO-BAND LIGATOR | Scandimed. A.S. | Nov 14, 2003 | SESE |
| [K033245](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K033245.md) | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | C.R. Bard, Inc. | Nov 6, 2003 | SESE |
| [K022434](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K022434.md) | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | C.R. Bard, Inc. | Aug 5, 2002 | SESE |
| [K013066](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K013066.md) | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | Olympus America, Inc. | Dec 11, 2001 | SESE |
| [K001744](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K001744.md) | OLYMPUS ENDOSCOPIC LIGATION DEVICE | Olympus America, Inc. | Feb 27, 2001 | SESE |
| [K990864](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K990864.md) | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 | Boston Scientific Corp | Jun 11, 1999 | SESE |
| [K984255](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K984255.md) | OLYMPUS HX-20 SERIES LIGATING DEVICE | Olympus Corp of America | Jan 12, 1999 | SESE |
| [K964661](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K964661.md) | HX-20/21-1 ENDOSCOPIC LIGATOR | Olympus America, Inc. | Oct 30, 1997 | SESE |
| [K971137](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K971137.md) | BARD RAPIDFIRE MULTIPLE BAND LIGATOR | C.R. Bard, Inc. | Oct 16, 1997 | SESE |
| [K944220](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K944220.md) | WILSON COOK MULTIPLE BAND LIGATOR | Wilson-Cook Medical, Inc. | Jan 24, 1995 | SESE |
| [K940661](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K940661.md) | STIEGMANN-GOFF ENDOSCOPIC LIGATOR | C.R. Bard, Inc. | Nov 28, 1994 | SESE |

## Top Applicants

- C.R. Bard, Inc. — 4 clearances
- Olympus America, Inc. — 3 clearances
- Scandimed International — 2 clearances
- Wilson-Cook Medical, Inc. — 1 clearance
- Scandimed. A.S. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND)

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