Accurett®
The FDA filing describes Accurett as a handheld cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold carbon dioxide gas. The carbon dioxide is…
The FDA filing describes Accurett as a handheld cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold carbon dioxide gas. The carbon dioxide is delivered in liquid phase to the selected area.
Before use, a commercially available 16 gauge carbon dioxide cartridge is loaded into the instrument. A trigger controls gas flow, and the filing identifies the Joule-Thompson principle as its cooling method.
Operating Details
The filing states the carbon dioxide output temperature is minus 79 degrees Celsius. Accurett shares its intended use with the cited predicate device, while the modification described in this submission is the cryogen source.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | H&O Equipments, Nv/Sa, Belgium |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| 510(k) | K161615 |
| Record published | 2021-09-21 |
| Record revised | 2021-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 16g cartridges for Accurett | 6 | In distribution | |
| Accurett | In distribution | ||
| 8g cartridges for Accurett | 24 | In distribution | |
| 16g CO2 cartridges | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| truFreeze | CSA Medical | 20 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161615 | 2016-08-23 |
| K024009 | 2003-03-20 |
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.