Home › Device types › KOB
Catheter, Suprapubic (And Accessories)
FDA product code KOB · Class 2 · Gastroenterology, Urology
479
Registered devices
205
Adverse events
66
Recalls
32
510(k) clearances
Devices with this code
MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.Stamey — COOK INCORPORATEDMiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.Stamey — COOK INCORPORATEDMiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) — FORTUNE MEDICAL INSTRUMENT CORP.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.O'Brien — COOK INCORPORATEDMiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.MiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.Mediplus — MEDIPLUS LTDUltrathane — COOK INCORPORATEDMiniSPC Button — APPLIED MEDICAL TECHNOLOGY, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-22 | Cook Inc. | Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotti |
| 2019-04-22 | Cook Inc. | Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotti |
| 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 |
| 2005-07-22 | Boston Scientific Corporation | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| 2005-07-22 | Boston Scientific Corporation | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| 2005-07-22 | Boston Scientific Corporation | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| 2005-07-22 | Boston Scientific Corporation | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| 2005-07-22 | Boston Scientific Corporation | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| 2005-07-22 | Boston Scientific Corporation | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
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