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Dilator, Urethral
FDA product code KOE · Class 2 · Gastroenterology, Urology
0
Registered devices
222
Adverse events
3
Recalls
27
510(k) clearances
Devices with this code
Cook — COOK INCORPORATEDAmplatz — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDV. Mueller — STERIS CORPORATIONBard® Eagle® Inflation Device — C. R. Bard, Inc.Cook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDPeel-Away — COOK INCORPORATEDAmplatz — COOK INCORPORATEDCook — COOK INCORPORATEDAmplatz — COOK INCORPORATEDQL Disposable Inflation Device — ATRION MEDICAL PRODUCTS, INC.Atala-Shepard — COOK INCORPORATEDAtala-Shepard — COOK INCORPORATEDQL Disposable Inflation Device — ATRION MEDICAL PRODUCTS, INC.Atrion QL4515 Inflation Device — ATRION MEDICAL PRODUCTS, INC.Peel-Away — COOK INCORPORATEDWellead Urethral Dilator — Well Lead Medical Co.,LtdUroMax Ultra — BOSTON SCIENTIFIC CORPORATIONUroMax Ultra — BOSTON SCIENTIFIC CORPORATIONV. Mueller — STERIS CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-04 | Cook 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 |
| 2019-01-04 | Cook 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 |
| 2005-08-01 | Cook Urological, Inc. | Mislabeled as to size. |
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