Home › Device types › FAJ
Cystoscope And Accessories, Flexible/Rigid
FDA product code FAJ · Class 2 · Gastroenterology, Urology
1,360
Registered devices
10,639
Adverse events
22
Recalls
92
510(k) clearances
Devices with this code
Medline — MEDLINE INDUSTRIES, INC.UROLIFT ® — SCHÖLLY FIBEROPTIC GmbHCystosure — EMMY MEDICAL LLCCystoscope — SOPRO-COMEG GmbHAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NA — STRYKER CORPORATIONUROLIFT ® — SCHÖLLY FIBEROPTIC GmbHSingle-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., LtdNA — STRYKER CORPORATIONAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.ENDO SMARTCAP — MEDIVATORS INC.Neoscope — PROSURG INCELECTROSURGICAL KNIFE — OLYMPUS MEDICAL SYSTEMS CORP.NA — STRYKER CORPORATIONENDO SMARTCAP — MEDIVATORS INC.Accessory for urology — SOPRO-COMEG GmbHNA — SCHÖLLY FIBEROPTIC GmbHAMNOTEC — AMNOTEC International Medical GmbHCYSTO-NEPHRO VIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.n.a. — Karl Storz GmbH & Co. KGStrauss Surgical — AMERICAN MEDICAL ENDOSCOPY, INC.AMNOTEC — AMNOTEC International Medical GmbHStrauss Surgical — AMERICAN MEDICAL ENDOSCOPY, INC.Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY, 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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