Olympus
4 catalogue numbers from WA47566S, listed by Olympus Winter & IBE Gmbh, Germany, under Electrode, Electrosurgical. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | JOS |
| Device type | Electrode, Electrosurgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-22 |
| Record revised | 2019-02-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WA47566S | 5 | In distribution | |
| WA47555S | 5 | In distribution | |
| WA47506S | 5 | In distribution | |
| WA47540S | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Assi | Accurate Surgical & Scientific Instruments Corp. | 55 |
| Cameron-Miller | Cameron-Miller, Inc. | 34 |
| Kirwan | Kirwan Surgical Products, LLC. | 30 |
| Empire microIncision Needle Electrodes | Cynosure, LLC | 27 |
| Round Loop Electrode | Cynosure, LLC | 22 |
| Oval Loop Electrode | Cynosure, LLC | 22 |
| Needle Electrode | Cynosure, LLC | 15 |
| Ball Electrode | Cynosure, LLC | 15 |
| Electrode, Electrosurgical | Richard Wolf Gmbh | 14 |
| Diamond Loop Electrode | Cynosure, LLC | 13 |
| Triangle Loop Electrode | Cynosure, LLC | 11 |
| Lletz Bayonet | Cynosure, LLC | 9 |
Showing 12 of 138. All products under Electrode, Electrosurgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161600 | 2016-09-06 |
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.