Panels › Gastroenterology, Urology › Product code MND · Class 2
Ligator, Esophageal
Regulation 876.4400
0510(k)s in 12 months (15 all time)
1recalls in 12 months (5 all time)
3recalls that name a 510(k)
Top companies in MND
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 4 | 0 |
| Olympus America, Inc. | 3 | 0 |
| Cook Endoscopy | 0 | 2 |
| Olympus Corporation of the Americas | 0 | 2 |
| Scandimed International | 2 | 0 |
| Boston Scientific Corp | 1 | 0 |
| Endochoice, Inc. | 1 | 0 |
| Ethicon Endo-Surgery, Inc. | 1 | 0 |
| Micro-Tech Usa | 0 | 1 |
| Olympus Corp of America | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2025 | Olympus Corporation of the Americas Brand Name: Single Use Ligating Device
Product Name: Olympus HX-400U-30
Model/Catalog Number: HX-400U-30
Used with an Olympus endoscope to deliver a nylon loop snare. Open, Classified |
MND | None listed |
| Apr 20, 2023 | Olympus Corporation of the Americas Single Use Rotatable Clip Fixing Device
Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip
Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip
Mode Open, Classified |
MND | K013066 |
| Oct 5, 2020 | Micro-Tech Usa Elastic Traction Device, 11mm Lower. UPN: ER56041
Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, expos Terminated |
MND | None listed |
| Jun 28, 2011 | Cook Endoscopy Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical
Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of en Terminated |
MND | K023903 |
| Oct 19, 2010 | Cook Endoscopy Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105
This device is used to endoscopically ligate esophageal varices at or above the g Terminated |
MND | K944220 |
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