Home › Device types › FAJ
Cystoscope And Accessories, Flexible/Rigid
FDA product code FAJ · Class 2 · Gastroenterology, Urology
1,449
Registered devices
11,796
Adverse events
22
Recalls
92
510(k) clearances
Devices with this code
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NA — STRYKER CORPORATIONOES ELITE — OLYMPUS Winter & Ibe GmbHCystoscopy sheath — SOPRO-COMEG GmbHNephroscopy sheath — SOPRO-COMEG GmbHVersaVue™ Tablet — MEDIMAGING INTEGRATED SOLUTION INC.ClearPetra — Well Lead Medical Co.,LtdAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY, INC.Cystoscopy adaptor — SOPRO-COMEG GmbHHOPKINS — Karl Storz GmbH & Co. KGHOPKINS — Karl Storz GmbH & Co. KGNephroscopy sheath — SOPRO-COMEG GmbHClearPetra — Well Lead Medical Co.,LtdOES ELITE — OLYMPUS Winter & Ibe GmbHAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.n.a. — Karl Storz GmbH & Co. KGNA — STRYKER CORPORATIONCystoscopy adaptor — SOPRO-COMEG GmbHNA — STRYKER CORPORATIONHOPKINS — Karl Storz GmbH & Co. KGClearPetra — Well Lead Medical Co.,LtdAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 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 |
| 2022-05-03 | Karl Storz Endoscopy | The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue. |
| 2022-04-20 | Olympus Corporation of the Americas | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading t |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
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