Concept Heatwave
60MM X 2.3MM Diameter, Concept Heatwave Electrode, QTY 5
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
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 | ConMed Corporation, United States |
|---|---|
| FDA product code | JOS |
| Device type | Electrode, Electrosurgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K991830 |
| Record published | 2016-09-24 |
| Record revised | 2024-08-12 (version 5) |
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 |
| Packaging | Box of 5 |
| Sizes | Outer diameter 2.3 mm; length 60 to 130 mm |
| Distribution end date | 2022-06-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CS-023 | Outer Diameter 2.3 mm | 5 | In distribution |
| CS-024 | Outer Diameter 2.3 mm | 5 | Withdrawn |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ConMed Corporation | 510(k) number | 2016-08-29 | Class II | Process change control | CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn. | Domestic: 1740; Foreign: 4770 | 2018-06-07 |
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.