Home › Device types › FBK
Endoscopic Injection Needle, Gastroenterology-Urology
FDA product code FBK · Class 2 · Gastroenterology, Urology
1,072
Registered devices
591
Adverse events
43
Recalls
89
510(k) clearances
Devices with this code
iSnare — US EndoscopyNA — Hangzhou AGS MedTech Co., Ltd.n.a. — Karl Storz GmbH & Co. KGSingle Use Injector NM600/610 — OLYMPUS MEDICAL SYSTEMS CORP.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.ZKSK — Beijing ZKSK Technology Co.,LtdNA — Hangzhou AGS MedTech Co., Ltd.Alton — Alton (Shanghai) Medical Instruments Co., Ltd.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.ZKSK — Beijing ZKSK Technology Co.,LtdSingle Use Injector NM600/610 — OLYMPUS MEDICAL SYSTEMS CORP.Injectra, Sclero Tip — Medi-Globe GmbHSclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.Single Use Injector NM600/610 — OLYMPUS MEDICAL SYSTEMS CORP.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.Single Use Injector — OLYMPUS MEDICAL SYSTEMS CORP.ZKSK — Beijing ZKSK Technology Co.,LtdDisposable Sclerotherapy Needle with Locking Cap — Telemed SystemsSclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd.Injection Needle — Jiangsu Vedkang Medical Science and Technology Co.,Ltd.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.iSnare — US Endoscopy
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-16 | Cook Incorporated | The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufac |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro |
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