Product code MND
- Device name
- Ligator, Esophageal
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4400
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132535 | AUTOBAND LIGATOR | Endochoice, Inc. | 2013-08-23 |
| K083556 | MODIFICATION TO AUTO-BAND LIGATOR | Scandimed International | 2009-02-19 |
| K081142 | AUTO-BAND LIGATOR | Scandimed International | 2008-05-16 |
| K051950 | INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 | Ethicon Endo-Surgery, Inc. | 2005-10-07 |
| K031236 | AUTO-BAND LIGATOR | Scandimed. A.S. | 2003-11-14 |
| K033245 | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | C.R. Bard, Inc. | 2003-11-06 |
| K022434 | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | C.R. Bard, Inc. | 2002-08-05 |
| K013066 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | Olympus America, Inc. | 2001-12-11 |
| K001744 | OLYMPUS ENDOSCOPIC LIGATION DEVICE | Olympus America, Inc. | 2001-02-27 |
| K990864 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 | Boston Scientific Corp | 1999-06-11 |
| K984255 | OLYMPUS HX-20 SERIES LIGATING DEVICE | Olympus Corp of America | 1999-01-12 |
| K964661 | HX-20/21-1 ENDOSCOPIC LIGATOR | Olympus America, Inc. | 1997-10-30 |
| K971137 | BARD RAPIDFIRE MULTIPLE BAND LIGATOR | C.R. Bard, Inc. | 1997-10-16 |
| K944220 | WILSON COOK MULTIPLE BAND LIGATOR | Wilson-Cook Medical, Inc. | 1995-01-24 |
| K940661 | STIEGMANN-GOFF ENDOSCOPIC LIGATOR | C.R. Bard, Inc. | 1994-11-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00724995247331 | SmartBand SafeGrip Multi-Band Ligation Kit | US Endoscopy | 2025-11-21 |
| 00724995247348 | SmartBand SafeGrip Multi-Band Ligation Pack | US Endoscopy | 2025-11-21 |
| 00724995247355 | SmartBand Ligation Kit | US Endoscopy | 2025-11-21 |
| 00724995247362 | SmartBand Ligation Pack | US Endoscopy | 2025-11-21 |
| 00850261006033 | SmartBand SafeGrip Multi-Band Ligation Kit | INTELLIGENT ENDOSCOPY LLC | 2017-08-01 |
| 00850261006019 | SmartBand Ligation Kit | INTELLIGENT ENDOSCOPY LLC | 2017-08-01 |
| 00850261006002 | SmartBand Ligation Pack | INTELLIGENT ENDOSCOPY LLC | 2017-08-01 |
| 10653405053644 | STIEGMANN-GOFF | Conmed Corporation | 2016-09-24 |
| 08714729201953 | Speedband Superview Super 7 | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 00827002268616 | Saeed | COOK INCORPORATED | 2016-09-24 |
| 30653405053686 | STIEGMANN-GOFF BANDITO | Conmed Corporation | 2016-09-24 |
| 10653405053668 | STIEGMANN-GOFF | Conmed Corporation | 2016-09-24 |
| 10653405053651 | STIEGMANN-GOFF | Conmed Corporation | 2016-09-24 |
| 04953170353093 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170254888 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170206979 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170206955 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170206924 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170206900 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170200229 | Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170200205 | Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170200182 | Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170194641 | SINGLE USE LIGATING DEVICE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170193040 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170193026 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170192999 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170192975 | Single Use Rotatable Clip Fixing Device | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170044922 | LIGATING DEVICE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170044861 | LIGATING DEVICE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170044809 | LIGATING DEVICE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |