Home › Device types › FBO
Cystourethroscope
FDA product code FBO · Class 2 · Gastroenterology, Urology
126
Registered devices
275
Adverse events
7
Recalls
19
510(k) clearances
Devices with this code
GREENLIGHT — Richard Wolf GmbHn.a. — Karl Storz GmbH & Co. KGElite — Gyrus ACMI, LLCNA — Richard Wolf GmbHn.a. — Karl Storz GmbH & Co. KGGREENLIGHT — Richard Wolf GmbHGyrus ACMI — Gyrus ACMI, LLCBiopsy Valve — OLYMPUS MEDICAL SYSTEMS CORP.E-LINE — Richard Wolf GmbHE-LINE — Richard Wolf GmbHGREENLIGHT — Richard Wolf GmbHE-LINE — Richard Wolf GmbHn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGLens Cleaner — OLYMPUS MEDICAL SYSTEMS CORP.MOXY — Richard Wolf GmbHGREENLIGHT — Richard Wolf GmbHPANOVIEW — Richard Wolf GmbHE-LINE — Richard Wolf GmbHGREENLIGHT — Richard Wolf GmbHn.a. — Karl Storz GmbH & Co. KGE-LINE — Richard Wolf GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2020-04-13 | American Contract Systems | The surgical gowns were manufactured in a facility that is not registered by the FDA. |
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