Home › Device types › KNY
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
RocaFlex Access Sheath & Dilation Catheter 12/14x45cm — PromeplaUroPass — Gyrus ACMI, LLCUreteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm — PromeplaUroPass — Gyrus ACMI, LLCBI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm — PromeplaSilhouette® Pediatric Ureteral Stent with Urowire® Guidewire — APPLIED MEDICAL RESOURCES CORPORATIONACUCISE® PROCEDURAL PACK — APPLIED MEDICAL RESOURCES CORPORATIONUroPass — Gyrus ACMI, LLCSTONE CENTER SILHOUETTE — APPLIED MEDICAL RESOURCES CORPORATIONBi-Flex — PromeplaUroPass — Gyrus ACMI, LLCACUCISE® PROCEDURAL PACK UNIVERSAL PACK B — APPLIED MEDICAL RESOURCES CORPORATIONVARI-PASS — Gyrus ACMI, LLCBard® "C" Clamp — C. R. Bard, Inc.UroPass — Gyrus ACMI, LLCRocaFlex Access Sheath & Dilation Catheter 10/12x45cm — PromeplaACUCISE® PROCEDURAL PACK STARTER PACK — APPLIED MEDICAL RESOURCES CORPORATIONACUCISE® CUSTOM KIT — APPLIED MEDICAL RESOURCES CORPORATIONUreteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm — PromeplaSilhouette® Pediatric Ureteral Stent with Urowire® Guidewire — APPLIED MEDICAL RESOURCES CORPORATIONDover — Cardinal Health 200, LLCUroPass — Gyrus ACMI, LLCACUCISE® PROCEDURAL PACK DELUXE STARTER PACK — APPLIED MEDICAL RESOURCES CORPORATIONUroPass — Gyrus ACMI, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-11 | Olympus Corporation of the Americas | Exposure 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 |
| 2023-05-19 | Olympus Corporation of the Americas | Dilator tips may break in the package and in patients during surgical procedures. |
| 2011-04-15 | Gyrus Acmi, Incorporated | Gyrus 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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