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Ligator, Esophageal
FDA product code MND · Class 2 · Gastroenterology, Urology
185
Registered devices
10,683
Adverse events
5
Recalls
15
510(k) clearances
Devices with this code
ZKSK — Beijing ZKSK Technology Co.,LtdSingle Use Rotatable Clip Fixing Device — OLYMPUS MEDICAL SYSTEMS CORP.ZKSK — Beijing ZKSK Technology Co.,LtdZKSK — Beijing ZKSK Technology Co.,LtdMultiple Band Ligator Set — Micro-Tech (Nanjing) Co., Ltd.SmartBand SafeGrip Multi-Band Ligation Kit — US EndoscopyLIGATING DEVICE — OLYMPUS MEDICAL SYSTEMS CORP.Saeed — COOK INCORPORATEDZKSK — Beijing ZKSK Technology Co.,LtdSmartBand Ligation Kit — INTELLIGENT ENDOSCOPY LLCZKSK — Beijing ZKSK Technology Co.,LtdZKSK — Beijing ZKSK Technology Co.,LtdSingle Use Rotatable Clip Fixing Device — OLYMPUS MEDICAL SYSTEMS CORP.Auto-Band® — ENDOCHOICE, INC.ZKSK — Beijing ZKSK Technology Co.,LtdMultiple Band Ligator Set — Micro-Tech (Nanjing) Co., Ltd.Multiple Band Ligator Set — Micro-Tech (Nanjing) Co., Ltd.ZKSK — Beijing ZKSK Technology Co.,LtdZKSK — Beijing ZKSK Technology Co.,LtdSingle Use Rotatable Clip Fixing Device — OLYMPUS MEDICAL SYSTEMS CORP.ZKSK — Beijing ZKSK Technology Co.,LtdSingle Use Rotatable Clip Fixing Device — OLYMPUS MEDICAL SYSTEMS CORP.Saeed — COOK INCORPORATEDZKSK — Beijing ZKSK Technology Co.,Ltd
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-30 | Olympus Corporation of the Americas | Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy |
| 2023-02-23 | Olympus Corporation of the Americas | There have been complaints that the clip did not come out of the tube sheath during the procedure. |
| 2020-10-05 | Micro-Tech Usa | FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in |
| 2011-06-07 | Cook Endoscopy | The disposable clip may not deploy after being positioned inside the patient. |
| 2010-09-03 | Cook Endoscopy | A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. This could result in a sec |
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