Pads
Dispersive pad connects to the generator
1manufacturer
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
Record
| Listed by | Halt Medical, Inc., United States |
|---|---|
| FDA product code | HFG |
| Device type | Coagulator, Laparoscopic, Unipolar (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4160 |
| Record published | 2016-09-19 |
| Record revised | 2023-09-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Conmed | ConMed Corporation | 12 |
| Acessa ProVu System | Hologic, Inc. | 8 |
| Generator | Halt Medical, Inc. | 1 |
| Guidance controller | Halt Medical, Inc. | 1 |
| Guidance field generator | Halt Medical, Inc. | 1 |
| Acessa ProVu Dual Foot Pedal | Acessa Health, Inc. | 1 |
| Guidance handpiece | Halt Medical, Inc. | 1 |
| Handpiece cable | Halt Medical, Inc. | 1 |
| Guidance handpiece cable | Halt Medical, Inc. | 1 |
| Guidance ultrasound transducer sleeve | Halt Medical, Inc. | 1 |
| Pad cable | Halt Medical, Inc. | 1 |
| Handpiece | Halt Medical, Inc. | 1 |
Showing 12 of 14. All products under Coagulator, Laparoscopic, Unipolar (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132744 | 2014-05-27 |
| K132184 | 2014-04-28 |
| K121858 | 2012-11-05 |
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.