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Endoscopic Guidewire, Gastroenterology-Urology

FDA product code OCY · Class 2 · Gastroenterology, Urology

1,040
Registered devices
1,635
Adverse events
10
Recalls
43
510(k) clearances

Devices with this code

Tracer Hybrid — COOK INCORPORATEDSingle Use Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.FXWIRE — Conmed CorporationZKSK — Beijing ZKSK Technology Co.,LtdSingle Use Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.Cook — COOK INCORPORATEDHydrophilic Guidewire for Urinary Tract — SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.Tracer Hybrid — COOK INCORPORATEDNovaGold — HERAEUS MEDICAL COMPONENTS LLCJagwire™ Revolution — BOSTON SCIENTIFIC CORPORATIONCook — COOK INCORPORATEDJagwire — BOSTON SCIENTIFIC CORPORATIONSingle Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.XWIRE — Conmed CorporationSingle Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.Single Use Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.Single Use Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD.ERCP — HERAEUS MEDICAL COMPONENTS LLCHydrophilic Guidewire for Urinary Tract — SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.Cook — COOK INCORPORATED

Recent recalls

DateFirmReason
2022-08-16Cook IncorporatedCook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the
2014-03-31NEO METRICS, INC.Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illnes

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.