Home › Device types › FBK
Endoscopic Injection Needle, Gastroenterology-Urology
FDA product code FBK · Class 2 · Gastroenterology, Urology
1,055
Registered devices
570
Adverse events
42
Recalls
89
510(k) clearances
Devices with this code
Injection Needle — Micro-Tech (Nanjing) Co., Ltd.NA — Hangzhou AGS MedTech Co., Ltd.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd.NA — Hangzhou AGS MedTech Co., Ltd.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.G-Flex — G-Flex EuropeZKSK — Beijing ZKSK Technology Co.,LtdZKSK — Beijing ZKSK Technology Co.,LtdSclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.Injectra, Sclero Tip — Medi-Globe GmbHNA — Hangzhou AGS MedTech Co., Ltd.Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd.Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.EndoTNeedle — ENDO-THERAPEUTICS, INC.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd.Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd.Single Use Injector — OLYMPUS MEDICAL SYSTEMS CORP.ZKSK — Beijing ZKSK Technology Co.,LtdSclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd.Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd.Sclerotherapy needle — Zhejiang Chuangxiang Medical Technology Co., LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if use |
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