Erbe
ERBOCRYO® CA Cryosurgical System, 120 V/60Hz, UL
3manufacturers in China registered for this device type
12catalogue numbers in this listing
4510(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 | Erbe Elektromedizin GmbH, Germany |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K190651 |
| Record published | 2020-03-11 |
| Record revised | 2019-08-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep away from heat and direct sunlight; Special storage condition: Keep dry; Storage environment temperature -20 to 55 °C; Handling environment temperature -20 to 55 °C; Storage environment humidity 15 to 80 % RH; Handling environment humidity 15 to 80 % RH |
| Packaging | Level 1 of 5, pack of 5 |
| Sizes | Length 900 to 2550 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10402-000 | In distribution | |
| 20402-410 | Length 1150 mm | In distribution |
| 20416-036 | Length 900.000 mm | In distribution |
| 20416-035 | In distribution | |
| 10448-004 | In distribution | |
| 20402-411 | Length 1150 mm | In distribution |
| 20416-031 | Length 900.000 mm | In distribution |
| 20711-009 | In distribution | |
| 20402-201 | In distribution | |
| 20402-501 | Length 2550 mm | In distribution |
| 20402-401 | Length 1150 mm | In distribution |
| 20402-402 | Length 1150 mm | 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 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 10 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261806 | 2026-06-09 |
| K253230 | 2026-04-22 |
| K190651 | 2020-01-07 |
| K934261 | 1994-04-26 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Erbe USA, Inc. | 510(k) number | 2026-06-26 | Class II | Device Design | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cry | 11226 units |
| Erbe USA, Inc. | 510(k) number | 2026-02-12 | Class I | Process control | Probes may rupture/burst during activation | 64216 units |
| Erbe USA, Inc. | 510(k) number | 2026-02-12 | Class I | Process control | Probes may rupture/burst during activation | 8,284 units |
| Erbe USA, Inc. | 510(k) number | 2026-02-12 | Class I | Process control | Probes may rupture/burst during activation | 3603 units |
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.