Guidance Handpiece Cable
Connects the Guidance Handpiece to the Acessa Generator and the Guidance Controller.
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 |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5400 | 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 ultrasound transducer sleeve | Halt Medical, Inc. | 1 |
| Pads | 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.