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Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
FDA product code GCA · Class 2 · Gastroenterology, Urology
136
Registered devices
441
Adverse events
2
Recalls
26
510(k) clearances
Devices with this code
Silicone T Drainage Tube — FORTUNE MEDICAL INSTRUMENT CORP.Silicone Y Drainage Tube — FORTUNE MEDICAL INSTRUMENT CORP.Taxi — Lake Region MedicalSilicone T Drainage Tube With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.SpyGlass™ Discover — BOSTON SCIENTIFIC CORPORATIONSilicone T Drainage Tube — FORTUNE MEDICAL INSTRUMENT CORP.Fusion Quattro — COOK INCORPORATEDMueller — COOK INCORPORATEDCook — COOK INCORPORATEDSilicone Y Drainage Tube — FORTUNE MEDICAL INSTRUMENT CORP.Ring — COOK INCORPORATEDCook — COOK INCORPORATEDMueller — COOK INCORPORATEDTri-Ex — COOK INCORPORATEDCook — COOK INCORPORATEDSilicone T Drainage Tube — FORTUNE MEDICAL INSTRUMENT CORP.Silicone T Drainage Tube With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.Ring — COOK INCORPORATEDSilicone T Drainage Set With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.Cook — COOK INCORPORATEDTri-Ex — COOK INCORPORATEDDURAGLIDE — Conmed CorporationIRR-023-10F — APPLIED MEDICAL RESOURCES CORPORATIONBouncer — COOK INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that |
| 2002-08-28 | Wilson-Cook Medical Inc | The product was labeled with a 5 year expiration date instead of a 1 year expiration date. |
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