CryoProbe™
35 catalogue numbers from CryoProbe O+, listed by H&O Equipments, Nv/Sa, Belgium, under Unit, Cryosurgical, Accessories. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
35catalogue numbers in this listing
2510(k) clearances naming this product code
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) | K024009 |
| Record published | 2023-03-12 |
| Record revised | 2021-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 12, pack of 36 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CryoProbe O+ | In distribution | ||
| 16g cartridges for CryoProbe | 6 | In distribution | |
| CryoProbe Touch | In distribution | ||
| CryoProbe|touch | In distribution | ||
| CryoProbe |b White | In distribution | ||
| CryoProbe B+ | In distribution | ||
| CryoProbe XPS | In distribution | ||
| CryoProbe M | In distribution | ||
| CryoProbe XP | In distribution | ||
| CryoProbe B+ | In distribution | ||
| CryoProbe|o | In distribution | ||
| CryoProbe|xgyn | In distribution | ||
| CryoProbe|o 2018 | In distribution | ||
| CryoProbe|b special aesthethics | In distribution | ||
| CryoProbe XP | In distribution | ||
| N2O 8g cartridges and filters | 10 | In distribution | |
| CryoProbe X+ | In distribution | ||
| CryoProbe|b+ | In distribution | ||
| CryoProbe X+ | In distribution | ||
| CryoProbe XP | In distribution | ||
| CryoProbe|x+ | In distribution | ||
| 23g cartridges for CryoProbe | 6 | In distribution | |
| CryoProbe|x+ 2018 | In distribution | ||
| 8g N2O cartridges | 24 | In distribution | |
| 16g N2O cartridges | 6 | In distribution | |
| CryoProbe|x | In distribution | ||
| CryoProbe|o medical aesthethic | In distribution | ||
| CryoProbe B+ | In distribution | ||
| CryoProbe XP+ | In distribution | ||
| 8g cartridges for CryoProbe | 24 | In distribution | |
| CryoProbe O | In distribution | ||
| CryoProbe|b Special HPV | In distribution | ||
| CryoProbe|m | In distribution | ||
| CryoProbe M | In distribution | ||
| 23g N2O cartridges | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| 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 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 10 |
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.