MND · Ligator, Esophageal
Gastroenterology, Urology · 21 CFR 876.4400 · Class 2
Overview
| Product Code | MND |
|---|---|
| Device Name | Ligator, Esophageal |
| Regulation | 21 CFR 876.4400 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
Cleared Devices (15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132535 | AUTOBAND LIGATOR | Endochoice, Inc. | Aug 23, 2013 | SESE |
| K083556 | MODIFICATION TO AUTO-BAND LIGATOR | Scandimed International | Feb 19, 2009 | SESE |
| K081142 | AUTO-BAND LIGATOR | Scandimed International | May 16, 2008 | SESE |
| K051950 | INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 | Ethicon Endo-Surgery, Inc. | Oct 7, 2005 | SESE |
| K031236 | AUTO-BAND LIGATOR | Scandimed. A.S. | Nov 14, 2003 | SESE |
| K033245 | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | C.R. Bard, Inc. | Nov 6, 2003 | SESE |
| K022434 | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | C.R. Bard, Inc. | Aug 5, 2002 | SESE |
| K013066 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | Olympus America, Inc. | Dec 11, 2001 | SESE |
| K001744 | OLYMPUS ENDOSCOPIC LIGATION DEVICE | Olympus America, Inc. | Feb 27, 2001 | SESE |
| K990864 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 | Boston Scientific Corp | Jun 11, 1999 | SESE |
| K984255 | OLYMPUS HX-20 SERIES LIGATING DEVICE | Olympus Corp of America | Jan 12, 1999 | SESE |
| K964661 | HX-20/21-1 ENDOSCOPIC LIGATOR | Olympus America, Inc. | Oct 30, 1997 | SESE |
| K971137 | BARD RAPIDFIRE MULTIPLE BAND LIGATOR | C.R. Bard, Inc. | Oct 16, 1997 | SESE |
| K944220 | WILSON COOK MULTIPLE BAND LIGATOR | Wilson-Cook Medical, Inc. | Jan 24, 1995 | SESE |
| K940661 | 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
