Kirwan
Disposable Cautery Variable High Temperature, Fine Tip
2manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Kirwan Surgical Products, LLC., United States |
|---|---|
| FDA product code | HQP |
| Device type | Unit, Cautery, Thermal, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4115 |
| Establishment | Manufacturer |
| 510(k) | K062659 |
| Record published | 2016-05-08 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 50, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41-6120 | In distribution | |
| 41-6115 | In distribution | |
| 41-6145 | In distribution | |
| 41-6130 | In distribution | |
| 41-6110 | In distribution | |
| 41-6135 | In distribution | |
| 41-6140 | In distribution | |
| 41-6125 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bovie | Aspen Surgical Products, Inc. | 28 |
| Endo Optiks® | Beaver-Visitec International, Ltd | 25 |
| Accu-Temp® | Beaver-Visitec International, Ltd | 12 |
| BVI | Beaver-Visitec International, Ltd | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Pro Advantage | National Distribution & Contracting Inc | 3 |
| Argent | Mckesson Medical-Surgical Inc. | 3 |
| Henry Schein | Henry Schein, Inc. | 3 |
| Medichoice | Owens & Minor Distribution, Inc. | 2 |
| Summit Medical | Summit Medical LLC | 2 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 2 |
| Hotsy | Shippert Medical Technologies Corp. | 2 |
Showing 12 of 14. All products under Unit, Cautery, Thermal, Battery-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062659 | 2007-03-09 |
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.