AED
Resectoscope sheath for continuous irrigation with standard obturator with central valve 27 CH
1manufacturer
24catalogue numbers in this listing
1510(k) clearance
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 | National Advanced Endoscopy Devices, Inc., United States |
|---|---|
| FDA product code | FJL |
| Device type | Resectoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2017-06-30 |
| Record revised | 2018-12-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2025-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 505L | In distribution | |
| 32-4297 | In distribution | |
| 32-4205IS | In distribution | |
| 32-4221ZV | In distribution | |
| 32-4205 | In distribution | |
| 32-4221 | In distribution | |
| 32-4291 | In distribution | |
| 32-4225 | In distribution | |
| 32-4205ZV | In distribution | |
| 32-4292 | In distribution | |
| 32-4305 | In distribution | |
| STZ-WE | In distribution | |
| HW5400 | In distribution | |
| 27050SM | In distribution | |
| 32-4220LR | In distribution | |
| HS5400 | In distribution | |
| 32-4221RR | In distribution | |
| 32-4305G | In distribution | |
| 32-4290 | In distribution | |
| 32-4205RR | In distribution | |
| MT1210 | In distribution | |
| 110-125QL | In distribution | |
| HW5400 | Withdrawn | |
| 32-4205RR | Withdrawn |
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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102663 | 2010-12-30 |
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.