Ligator, Esophageal
FDA product code MND · Class II (moderate risk) · 21 CFR 876.4400 · Gastroenterology, Urology
15510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132535 | Autoband LigatorMND · Special | Endochoice, Inc. | 08/23/2013SE |
| K083556 | Modification to Auto-Band LigatorMND · Special | Scandimed International | 02/19/2009SE |
| K081142 | Auto-Band LigatorMND · Special | Scandimed International | 05/16/2008SE |
| K051950 | Inscope Multi-Clip Applier, Models IN22321, IN23321MND · Traditional | Ethicon Endo-Surgery, Inc. | 10/07/2005SE |
| K031236 | Auto-Band LigatorMND · Traditional | Scandimed. A.S. | 11/14/2003SE |
| K033245 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Special | C.R. Bard, Inc. | 11/06/2003SE |
| K022434 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Traditional | C.R. Bard, Inc. | 08/05/2002SE |
| K013066 | HX-5/6-1 Endoscopic Clipping DeviceMND · Traditional | Olympus America, Inc. | 12/11/2001SE |
| K001744 | Olympus Endoscopic Ligation DeviceMND · Traditional | Olympus America, Inc. | 02/27/2001SE |
| K990864 | Speedband Superview Multiple Band Ligator, Models 4225, 4228MND · Traditional | Boston Scientific Corp | 06/11/1999SE |
| K984255 | Olympus HX-20 Series Ligating DeviceMND · Traditional | Olympus Corp of America | 01/12/1999SE |
| K964661 | HX-20/21-1 Endoscopic LigatorMND · Traditional | Olympus America, Inc. | 10/30/1997SE |
| K971137 | Bard Rapidfire Multiple Band LigatorMND · Traditional | C.R. Bard, Inc. | 10/16/1997SE |
| K944220 | Wilson Cook Multiple Band LigatorMND · Traditional | Wilson-Cook Medical, Inc. | 01/24/1995SE |
| K940661 | Stiegmann-Goff Endoscopic LigatorMND · Traditional | C.R. Bard, Inc. | 11/28/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0570-2026 Class I | Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog…Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to… | Olympus Corporation of the Americas | 10/30/2025Open, Classified |
| Z-1418-2023 Class II | Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8…There have been complaints that the clip did not come out of the tube sheath during the procedure. | Olympus Corporation of the Americas | 02/23/2023Open, Classified |
| Z-0470-2021 Class II | Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N -…FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I… | Micro-Tech Usa | 10/05/2020Terminated |
| Z-2691-2011 | Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product…The disposable clip may not deploy after being positioned inside the patient. | Cook Endoscopy | 06/07/2011Terminated |
| Z-0092-2011 | Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station…A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the… | Cook Endoscopy | 09/03/2010Terminated |