Olympus
4 catalogue numbers from WA50011A, listed by Olympus Winter & IBE Gmbh, Germany, under Endoscope, Accessories, Narrow Band Spectrum. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | NWB |
| Device type | Endoscope, Accessories, Narrow Band Spectrum |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K090980 |
| Record published | 2016-09-21 |
| Record revised | 2022-08-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2019-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WA50011A | Withdrawn | |
| WA50013L | Withdrawn | |
| WA50015L | Withdrawn | |
| WA50013A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 10 |
| Medisono | Medisono, LLC | 10 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 8 |
| Rhino-Laryngo Videoscope | Olympus Medical Systems Corp. | 7 |
| Evis Exera II Gastrointestinal Videoscope | Olympus Medical Systems Corp. | 7 |
| Visera Cysto-Nephro Videoscope | Olympus Medical Systems Corp. | 6 |
| Uretero-Reno Videoscope | Olympus Medical Systems Corp. | 4 |
| Cysto-Nephro Videoscope | Olympus Medical Systems Corp. | 4 |
| Foot Holder | Olympus Medical Systems Corp. | 3 |
| Light source cable | Olympus Medical Systems Corp. | 3 |
| Foot Switch | Olympus Medical Systems Corp. | 3 |
| Evis Exera II Duodenovideoscope | Olympus Medical Systems Corp. | 3 |
Showing 12 of 66. All products under Endoscope, Accessories, Narrow Band Spectrum
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090980 | 2009-06-29 |
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.