Accurett
510(k) K161615
Accurett is a medical device (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by H&O Equipments nv/sa, cleared under FDA 510(k) K161615 on 23 Aug 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161615 | Date23 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K161615
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEH
- FDA applicant
- H&O Equipments, Nv/Sa
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161615
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Accurett | S-ACT-10 / Accurett | B386SACT100 | On the market | |
| Accurett 16g CO2 cartridges | S-CO2-16G-BOX / 16g CO2 cartridges | B386SCO216GBOX1 | On the market | |
| Accurett® 16g cartridges for Accurett | S-CO2-16G-BOX / 16g cartridges for Accurett | 15407008486102 | On the market | |
| Accurett® 8g cartridges for Accurett | S-CO2-8G-BOX / 8g cartridges for Accurett | 15407008486003 | On the market | |
| Acurrett® Accurett 8G | S-ACT-8 / Accurett 8G | B386SACT80 | On the market |
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