Olympus
Grasping forceps, three-nail, with working channel 1.1 mm, 3.5 x 400 mm
1manufacturer
22catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | FGA |
| Device type | Kit, Nephroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K853486 |
| Record published | 2016-09-21 |
| Record revised | 2025-10-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2022-12-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WA33038A | In distribution | ||
| WA33027A | In distribution | ||
| WA37031A | In distribution | ||
| WA63815A | In distribution | ||
| WA63821A | 20 | In distribution | |
| WA33039A | In distribution | ||
| WA33026A | In distribution | ||
| WA63813A | In distribution | ||
| A3342 | In distribution | ||
| WA33028A | In distribution | ||
| A37022A | In distribution | ||
| WA33037A | In distribution | ||
| WA33025A | In distribution | ||
| WA63810A | In distribution | ||
| WA33036A | In distribution | ||
| 00131 | 10 | In distribution | |
| WA63819A | In distribution | ||
| WA33040A | In distribution | ||
| WA63817A | In distribution | ||
| A37025A | Withdrawn | ||
| WA33024A | Withdrawn | ||
| WA33035A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kit, Nephroscope | Karl Storz GmbH & Co. KG | 43 |
| Cardinal Health | Cardinal Health 200, LLC | 20 |
| MIP Minimal Invasive Pcnl | Karl Storz GmbH & Co. KG | 19 |
| Strauss Surgical | American Medical Endoscopy | 14 |
| Kit, Nephroscope | Schölly Fiberoptic GmbH | 12 |
| Kit, Nephroscope | Richard Wolf Gmbh | 4 |
| Panoview Plus | Richard Wolf Gmbh | 4 |
| Panoview | Richard Wolf Gmbh | 2 |
| Halogen Light Source | Olympus Medical Systems Corp. | 2 |
| Coagulation Electrode | Olympus Medical Systems Corp. | 1 |
| Monarch™ Mini-PCNL Suction Set | Auris Health, Inc | 1 |
| OES Cystonephrofiberscope | Olympus Medical Systems Corp. | 1 |
Showing 12 of 16. All products under Kit, Nephroscope
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.