Shark
SHEATH RESECTOSCOPE 26FR color code black, SL 201 mm, round, rotatable, slanted distal end, ceramic, intermittent flushing, compatible with Shark irrigation adaptor 8676354 or 8676361, and…
SHEATH RESECTOSCOPE 26FR color code black, SL 201 mm, round, rotatable, slanted distal end, ceramic, intermittent flushing, compatible with Shark irrigation adaptor 8676354 or 8676361, and telescopes Ø 4 mm, 0°/12°/30°, Snap-On lock, reusable
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 | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | FJL |
| Device type | Resectoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2024-12-02 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH |
| Sizes | Outer diameter 7.33333 to 8.66667 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8676426 | Outer Diameter 8.66666666666 mm | In distribution |
| 8676342 | Outer Diameter 8 mm | In distribution |
| 8675424 | Outer Diameter 8 mm | In distribution |
| 8675426 | Outer Diameter 8.66666666666 mm | In distribution |
| 8673126 | Outer Diameter 8.66666666666 mm | In distribution |
| 8676343 | In distribution | |
| 8673124 | Outer Diameter 8 mm | In distribution |
| 8676326 | Outer Diameter 8.66666666666 mm | In distribution |
| 8673024 | Outer Diameter 8 mm | In distribution |
| 8673026 | Outer Diameter 8.66666666666 mm | In distribution |
| 8676324 | Outer Diameter 8 mm | In distribution |
| 8673122 | Outer Diameter 7.33333333333 mm | In distribution |
| 8675322 | Outer Diameter 7.33333333333 mm | In distribution |
| 8676424 | Outer Diameter 8 mm | In distribution |
| 8673226 | Outer Diameter 8.66666666666 mm | In distribution |
| 8676361 | In distribution | |
| 8673224 | Outer Diameter 8 mm | In distribution |
| 8675324 | Outer Diameter 8 mm | In distribution |
| 8673324 | Outer Diameter 8 mm | In distribution |
| 8673022 | Outer Diameter 7.33333333333 mm | In distribution |
| 8676354 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Olympus | Olympus Winter & IBE Gmbh | 58 |
| E-Line | Richard Wolf Gmbh | 33 |
| Ureterorenoscope | Sopro-Comeg GmbH | 28 |
| AED | National Advanced Endoscopy Devices, Inc. | 24 |
| 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
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-06-25 | Class II | Under Investigation by firm | Product labeled as Cutting Electrode may contain BIVAP electrode. | 20 boxes | 2024-01-05 |
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.