Olympus
Inner sheath, long, for WA22018A/19A, with deflecting tip obturator
1manufacturer
58catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | FJL |
| Device type | Resectoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K904940 |
| Record published | 2016-09-21 |
| Record revised | 2025-10-28 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2024-05-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WA22306S | 5 | In distribution | |
| A3559 | In distribution | ||
| A42011A | In distribution | ||
| A3558 | In distribution | ||
| WA22558S | 5 | In distribution | |
| A22051A | In distribution | ||
| A22054A | In distribution | ||
| A22041T | In distribution | ||
| A3556 | In distribution | ||
| A3557 | In distribution | ||
| A22040T | In distribution | ||
| A22042T | In distribution | ||
| A3560 | In distribution | ||
| A3550 | In distribution | ||
| WA22017T | In distribution | ||
| A22040A | In distribution | ||
| A22052A | In distribution | ||
| WA22521S | 5 | In distribution | |
| A3551 | In distribution | ||
| A22042A | In distribution | ||
| WA22539S | 5 | In distribution | |
| A22041A | In distribution | ||
| WALP14MS | 5 | In distribution | |
| WA22351S | 5 | In distribution | |
| A4676A | In distribution | ||
| A3555 | In distribution | ||
| WA22537S | 5 | In distribution | |
| WALP08MS | 5 | In distribution | |
| A22053A | In distribution | ||
| A4677A | In distribution | ||
| A0336.1 | In distribution | ||
| WA22503S | 5 | In distribution | |
| A2661 | Withdrawn | ||
| WA47055S | 5 | Withdrawn | |
| A22043T | Withdrawn | ||
| WA22222S | 5 | Withdrawn | |
| WALP04MS | 5 | Withdrawn | |
| A22043A | Withdrawn | ||
| WA22211S | 5 | Withdrawn | |
| WALP35MS | 5 | Withdrawn | |
| WA47051S | 5 | Withdrawn | |
| A3764A | Withdrawn | ||
| A2588 | Withdrawn | ||
| A22014A | Withdrawn | ||
| WAND20MS | 5 | Withdrawn | |
| WACL21MS | 5 | Withdrawn | |
| WABD09MS | 5 | Withdrawn | |
| A22055A | Withdrawn | ||
| WARL23MS | 5 | Withdrawn | |
| WA22203S | 5 | Withdrawn | |
| WARN25MS | 5 | Withdrawn | |
| WA22201S | 5 | Withdrawn | |
| A0418 | Withdrawn | ||
| WACL28MS | 5 | Withdrawn | |
| WA47053S | 5 | Withdrawn | |
| A2589 | Withdrawn | ||
| A3765A | Withdrawn | ||
| A2660 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| E-Line | Richard Wolf Gmbh | 33 |
| Ureterorenoscope | Sopro-Comeg GmbH | 28 |
| AED | National Advanced Endoscopy Devices, Inc. | 24 |
| Shark | Richard Wolf Gmbh | 21 |
| Urology syringe | Sopro-Comeg GmbH | 15 |
| Resectoscope | Richard Wolf Gmbh | 14 |
| Resectoscope | Karl Storz GmbH & Co. KG | 11 |
| Panoview | Richard Wolf Gmbh | 8 |
| Urology Evacuator | Sopro-Comeg GmbH | 7 |
| Piranha | Richard Wolf Gmbh | 6 |
| Veloxion | Aulea Medical, Inc. | 6 |
| Gimmi | Gimmi Gmbh | 5 |
Showing 12 of 18. All products under Resectoscope
Recalls Naming This Product
18 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 29 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 6,949 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 7,426 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 3,484 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 2,626 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 1,676 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 1,634 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 118 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 207 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 9 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 899 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 437 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 1,141 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 1 unit |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 1 unit |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 0 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 0 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 0 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.