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Accessories, Catheter, G-U

FDA product code KNY · Class 2 · Gastroenterology, Urology

57
Registered devices
392
Adverse events
3
Recalls
65
510(k) clearances

Devices with this code

Dover — Cardinal Health 200, LLCBard® "C" Clamp — C. R. Bard, Inc.ACUCISE® PROCEDURAL PACK STARTER PACK — APPLIED MEDICAL RESOURCES CORPORATIONUroPass — Gyrus ACMI, LLCBI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cm — PromeplaRocaFlex Access Sheath & Dilation Catheter 10/12x35cm — PromeplaSilhouette® Pediatric Ureteral Stent with Urowire® Guidewire — APPLIED MEDICAL RESOURCES CORPORATIONBard® Drainage Protector and Catheter Plug — C. R. Bard, Inc.UroPass — Gyrus ACMI, LLCACUCISE® PROCEDURAL PACK UNIVERSAL PACK B — APPLIED MEDICAL RESOURCES CORPORATIONUroPass — Gyrus ACMI, LLCGYRUS ACMI, INC — Gyrus ACMI, LLCUroPass — Gyrus ACMI, LLCACUCISE® PROCEDURAL PACK — APPLIED MEDICAL RESOURCES CORPORATIONUroPass — Gyrus ACMI, LLCACUCISE® PROCEDURAL PACK — APPLIED MEDICAL RESOURCES CORPORATIONn.a. — Karl Storz GmbH & Co. KGSTONE CENTER SILHOUETTE — APPLIED MEDICAL RESOURCES CORPORATIONBI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm — PromeplaHalyard — Avanos Medical, Inc.ACUCISE® PROCEDURAL PACK UNIVERSAL PACK D — APPLIED MEDICAL RESOURCES CORPORATIONUreteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm — PromeplaACUCISE® CUSTOM KIT — APPLIED MEDICAL RESOURCES CORPORATIONACUCISE® PROCEDURAL PACK FEMALE PACK C — APPLIED MEDICAL RESOURCES CORPORATION

Recent recalls

DateFirmReason
2024-09-11Olympus Corporation of the AmericasExposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the pa
2023-05-19Olympus Corporation of the AmericasDilator tips may break in the package and in patients during surgical procedures.
2011-04-15Gyrus Acmi, IncorporatedGyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a resu

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