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Catheter, Ureteral, General & Plastic Surgery

FDA product code GBL · Class N · Gastroenterology, Urology

61
Registered devices
135
Adverse events
2
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
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
2016-04-15Cook Inc.Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function,

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